EMPLOYEE($) SIGNATURE . ~M~ _/;,i _\)). Jamie L. C. Dion, Investigator\ }..., '.J.v.J. ''Z-­Brent 1•1. Higgs, Investigator

SEE REVERSE Daniel J. Lahar, Investigator

~<.L-J 7 s-­OF THIS PAGE Isabel Y. Espinosa , Investigator Gloria A. Milster, Investigator Edith M. Gonzalez, Investigator

DATE ISSUED

10/29/2012

t'Oit\1 fDA ~83 (09108) PRE\~OliS EDITION OBSOLETE INSPECTIONAL OllSERVATIONS PAGE I OF II PAGES

DEPARTMENT 01' HEALTH AND HUMAN SERVICES FOOD AND DRUG AD;>.1INISTRATION

DISTRICT ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION

6th & Kipling St. (P.O. Box 25087) 09/17/2012 - 10/16/2012* Denver, co 80225-0087 FEINUMBER

(303) 236-3000 Fax: (303) 236-3100 1000117188 Industry Information: www.fda.gov/oc/industry NAME AND TITLE OF INDIVIDUAL TO miOM REPORT ISSUED

TO: Jimmie D. Shearer, President FIRM NAME STREET ADDRESS

Sunland, Inc. 42593 us Highway 70 CITY, STATE, Z IP CODE, COUNTRY TYPE ESTABLISHMENT INSPECTED

Portales, NM 88130 Peanut Butter Manufacturer

This document lists observations made by the FDA representative(s) during the inspection of your facility. They arc inspectional observations, and do not represent a final Agency determination regarding your compliance. Ifyou have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. Ifyou have any questions, please contact FDA at the phone number and address above.

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1

Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.

Specifically,

A. Since 2009, your firm has distributed lots ofpeanut butter and nut butters that were positive for Salmonella. The following is a list of products since 2009 that have been manufactured by your firm, have tested positive for Salmonella by your firm's internal testing program, and were at least partially distributed by your firm.

Date Product ID Product Type Salmonella T_J'Q_e 6/1 0/2009 040048 Peanut Butter S. Newport 6/10/2009 000436 Peanut Butter S. NewQ_Oit 6/ 10/2009 000437 Peanut Butter S. Newport 6/10/2009 000439 Peanut Butter S. Ne\',:_p_ott 6/10/2009 000438 Peanut Butter S.Newp01t 8/30/2009 026909 Peanut Butter S. Othmarschen,or S.

Oranienburg, or S. Winston, or S. Oak~

3/20/2010 081955 Peanut Butter S. Dallgow 3/20/2010 003385 Peanut Butter S. Dallgow 2/2/2011 030917 Peanut Butter S. Dallgow

AMENDMENT1

DEPARTMENT OF HEALTH AND HUi\L\N SERVICES FOODAND DRUG ADl\fiNISTRATION

DISTRICT ADDRESS AND PHONE NUMBER

6th & Kipling S t . (P.O. Bo x 2 5 087) Denver, co 80225-0087 (303) 236-3000 Fax: (303) 236-3100 Industry Information: www.fda.go v / oc / industry NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED

TO: Jimmie D. Shearer, President FIRM NAME

Sunland, Inc. CITY, STATE. ZIP CODE. COUNTRY

Portales, NM 88130

STR EET ADDRESS

42593 us Highway 70 TYPE ESTABLISHMENT INSPECTED

Peanut Butter Manufacturer

DATE(S) OF INSPECTION

09 /17 / 2012 - 10/ 16/ 2012* FEI NUMSER

1000117188

EMPLOYEE($) SIGNATURE DATE ISSUED

Jamie L. c. Dion, Investiga t or 'jJ;) Brent ~1 . Higgs , Inves t i gator Danie l J . Lahar, I nve s t i gatorSEE REVERSE I sabe l Y. Espinosa, Investigator ..iJr1 £__ 1 0/2 9/2012OF THIS PAGE Gloria A. Milster, Inves tigator Edi t h M. Gonzalez , I nve stigator

FORM FDA 483 (09/0&) PRE\~OUS EDITION OBSOLETE INSPECTIONAL OllSERVATIONS PAGE 2 OF II PAGES

8/ 18/2011 000004 Peanut Butter S.Arapahoe 8/ 19/2011 000050 Peanut Butter S. Teddington 8/ 19/2011 000051 Peanut Butter S. Teddington 8/ 19/2011 000050 Peanut Butter S. Cerro 9/ 19/2011 071119 Peanut Butter S. Mbandaka 9/23/2011 000432 Peanut Butter S. Mbandaka 9/23/2011 071119 Peanut Butter s. MaaRaalm

S. Kubacha 6/ 19/2012 01120 l Peanut Butter S. Bredeney 7/ 14/2012 026704 Peanut Butter S. Breden~ 8/23/2012* 002334 Almond Butter S. Meleagridis 8/23/2012 900251 Almond Butter S. Meleagridis 8/23/2012 900250 Almond Butter S. Meleagridis

(* This lot of Almond Butter was pat1 ofa composite that tested positive for S. Meleagridis by your firm and was released by Quality Control for distribution. At the time of the Observation this lot had not been distributed.)

B. During the current inspection, the following samples of finished products were collected from your firm by FDA and tested positive for Salmonella. The products listed below were not identified as being positive for Salmonella by your firm.

Date of Manufacturing

Product Sample#

Product ID Product Type Salmonella Type

05/22/2012 501133 071119 Peanut Butter S. Bredeney 05/23/2012 501134 071119 Peanut Butter S. Bredeney 06/20/2012 501140 000007 Peanut Butter In-progress 06/20/2012 501143 011 202 Peanut Butter In-progress 09/20/2012 501148 013210 Shelled Raw

Valencia Peanuts

In-progress

C. Dming the current inspection, the following environmental samples were collected from yom firm by FDA and tested positive for Salmonella:

AMENDMENT 1

DEPARHIENT OF HEALTH AND HUl\IAN SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS AND PHO~E NUMBER

6th & Kipling St. (P.O. Box 25087} Denver, co 80225-0087 (303} 236-3000 Fax: (303} 236-3100 Industry Information: www . fda.gov/oc/industry

DATE(S) OF INSPECTION

09/17/2012 - 10/16/2012* FEINUMBER

1000117188

NAME AND TinE OF INDIVIDUAL TO WHml REPORT ISSUED

TO: Jimmie D. Shearer, President FIRM NAME

Sunland, Inc .

STREETADDRESS

42593 us Highway 70 CITY. STATE. ZIP CODE. COUNTRY

Portales, NM 88130

TYPE ESTABLISHMENT INSPECTED

Peanut Butter Manufacturer

SEE REVERSE OF THIS PAGE

EMPLOYEE(S) SIGNATURE

Jamie L. C. Dion, Investigator ~ Brent 1•1. Higgs, Investigator Danie l J. Lahar, Investigator Isabel Y. Espinosa, Investigator Jl(£ Gloria A. Milster, Investigator Edith 14. Gonzalez, Investigator

DATE ISSUED

10/29/2012

FOil.\I FDA 483 (09/08) PRE\~OUS EDITIOll OBSOLETE JNSPECTJONAL ODSEin'ATIONS PAGE J OF ll PAGES

Sample/Sub# Location -Peanut Butter Plant Salmonella Type

INV722 I 53/I Peanut Butter Plant: Roasting Room, NW corner of the air duct located on

the north side of Roasting Room.

In-progress

INV722153/3 Peanut Butter Plant, Roasting Room, Cement floor crevice just off theE

corner of2nd N011h wallj-box from NE corner.

In-progress

INV722 I 53/4 Peanut Butter Plant: Roasting Room, Area just below hopper base of in-feed

elevator E. corner.

In-progress

INV722153/5 Peanut Butter Plant: Roasting Room, Gouge in cement crack just W. of the in-feed elevator leg and E of the drain.

In-progress

INV722153/7 Peanut Butter Plant: Roasting Room, In-progress Underside of metal plate covering E.

Drain. INV722153/8 Peanut Butter Plant, Roasting Room, E.

front leg of water heater located in the SE corner of the room.

In-progress

INV722153/9 Peanut Butter Plant, Roasting Room, Area next to theW. fi·ont leg of water

heater in SE corner of room.

In-progress

INV722153/10 Peanut Butter Plant, Roasting Room, In-progress Bristles of red handled broom hanging

on E. wall next to water heater. INV722153/ll Peanut Butter Plant, Roasting Room,

Bristles of red handled large push broom hanging on E. wall next to water

heater.

In-progress

INV722153/ 12 Peanut Butter Plant, Roasting Room, Bristles ofsecond red handled broom

hanging on E. wall next to water heater.

In-progress

INV722153/ 13 Peanut Butter Plant, Roasting Room, Area under compressor located just W

of water heater.

S. Senftenberg

AMENDMENT 1

Dl::l'ARTMENT OF II EALTII AND UllMAN SERVICES FOOD AND Ol{UG ADMINISTRATION

DISTRICT AOORESS AND PHON£ tiUYBER CATEjS) OF INSPECTIO:I

6th & Kipling St. (P.O. Box 25087) 09/17/2012 - 10/16/2012* FEIMJIIBERDenver, co 80225-0087

(303) 236 - 3000 Fax: (303) 236 - 3100 1000117188 Industry Informat ion: www.fda .gov/oc/industry NAME AND TmE OF INDIVIDUAL TO \'.HOM REPORT ISSUED

TO: Jimmie D. Shearer, President FIRM NN.•E

Sunland, Inc. CllY, STATE, ZlPCOOE, COUNTRY

Portales, NM 881 30

STREET ADDRESS

42593 US Highway 70 TYPE ESTA6U$H~!EIIT INSPECTED

Peanut Butter Manufacturer

Location - Peanut Butter Plant

in raw room.

Salmonella Type Sample/Sub#

Peanut Butter Plant, Roasting Room, S. Senftenberg Floor area around N. support bracket of

ressor. 1NV722153!16

INV722 153/1 4

Peanut Butter Plant, Roasting Room, S. Montevideo 3'd Roaster leg from E raw entrance of

the roaster on S side of room. INV722153/2 1 Peanut Butter Plant, Roasting Room, S. Bredcncy

Gap between floor and S wall - I ft W of red line.

INV7221 Peanut Butter Plant, Roast ing Room, S. Bredeney Top cover ofscrew conveyer that canies peanuts to the th1·ee bins in

roast room. IN V722153/61 Peanut Butter Plant, Roasting Room, S. Brcdeney

Bristles of green hand led push broom hanging on theW. wall next to entrance

door and warehouse door. INV7221 Peanut Butter Plant, Roasting Room, S. Mbandaka

Bristles of green handled push broom hanging on theW. wall next to the entrance door and warehouse door.

INV722153/73 Peanut Butter Plant, Roasting Room, S. Mbandaka Main center hopper middle support leg,

closest to S wall. INV722153/74 S. Montevideo

In-progresslN¥722155/230

In-progress INV722 1

INV722156/3 15 S. Mbnndnka

INV722156/331 Peanut Butter Plant: Raw Room, S. Meleagridis Bristles of Red handled broom in the

SEE REVERSE OF THIS PAGE

T\JRE AMENDMENT1

Jamie L. C. Oion, Investigator -:\1:;> Brent W. tl i ggs, I nvestigator Dani e l J. Lahar, I nvestigator Isabel Y. Espinosa, Investigator ~{{ Gl or i a A. Mi l ster, I nvestigator Edith M. Gonzal ez , I nvestigator

DATE ISSUED

10/29/2012

FOiiM FDA ~83 (09103) fREVIOUS f DITIO:< OBSOLETE JNSPECTIONA L ORSERVATIONS PAGE 4 OF II PAGES

DEPARTMENT OF HEALTH AND HUi\IAN SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS AND PHO~ENUMBER

6th & Kipling St . (P.O. Box 25087) Denver, co 80225-0087 (303) 236-3000 Fax : (303) 236-31 00 Industry Information: "TWw.fda:gov/oc/industry

OATE(S) OF INSPECTION

09/17/2012 - 10/16/2012* FEINUMBER

1000117188

NAME AND TITLE OF INDIVIDUAL TO \'hiOM REPORT ISSUED

TO: Jimmie D. Shearer, President FIRMNAA'E

Sunland , Inc . CITY. STATE, ZIP CODE. COUNTRY

Portales, NM 88130

STREET ADDRESS

42593 us Highway 70 TYPE ESTABLISHMENT INSPECTED

Peanu t Butter Manufactur er

EMPLOYE~($) SIGNATURE DATE ISSUED

SEE REVERSE OF THIS PAGE

Jamie L. C. Dion, Investigator J~ Brent I~. Higgs, Investigator Daniel J. Lahar, Investigator Isabel Y. Espi nosa, Investigator~£ Gloria A. l<lil ster, Investigator Edith 1·1. Gonzalez, Investigator

1 0/29/201 2

f'OR.\1 FDA ~83 (09/0S) PRE\'IOUS EDITIO~ OBSOLETE JNSPECTIONAL OBSERVATIONS PAGE 5 OF ll PAGES

SamJJle/Sub# Location -Peanut Butter Plant Salmonella Type

SE corner of Raw Peanut Receiving Room.

Sample/Sub# Location - Peanut Plant Salmonella ~e INV722156/400 Peanut Plant, Roasting Room, Floor

junction middle of cement filled area (where a wall used to be).

S. Anatum

INV77496 1 /429 Peanut Plant, Picking R. eld area of metal plate just above 1 pick line in pickil~room.

In-progress

INV77496 l/43 l Peanut Plant, Picking Room, Pick room vacuum.

In-progress

1NV774961 /465 Peanut Plant, Production Room, Floor area on NW comer ofscale platform located under shelled jumbo tank hopper.

In-progress

INV77496l/482 Peanut Plant, Salt/Bringing Room, Handle attached to top of brine basket.

In-progress

OBSERVATION 2

Failure to handle equipment, containers and utensils used to convey, hold, and store food in a manner that protects against contamination.

Specifically,

A. Specifically, the production and packaging lines ofequipment in the Peanut Butter Plant were not cleaned after each time Salmonella was isolated from peanut and nut butter products between 2009 and 2012.

i. There are no records to document the cleaning of the production and packaging lines after

AMENDMENT1

DF:PARTl\I£NT OP II£ALTII AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS A~O PHO~'f NUMBER

6th & Kipling St. (P.O. Box 25087) Denver, CO 80225 - 0087 (303) 236-3000 Fax : (303) 236-3100 Industry Information : \'JW\oJ.fda.gov/oc/industry NAME AND TmE Of INDIVIDUAL TO\NHOM REPORT ISSUED

TO: Jimmie D. Shearer, President

DATE(S) OF INSPECTION

09/1 7/2012 - 10/16/2012* FEI NUMBER

1000117188

FIR>,\ NAME

Sunland, Inc. CITY, STATE, ZIP CODE, COUNTRY

Portales, NM 88130

STREET ADORES$

42593 us Highway 70 TYPE ESTA6LISHMENT INSPECTED

Peanut Butter Manufacturer

EMPLOYEE($) S!GNATURE DATE ISSUED

Jamie L. C. Dion, I nvestigator cJl> Brent N, Hi ggs, Investigator

SEE REVERSE OF THIS PAGE

Daniel J . Isabel Y. Gl oria A.

Lahar, Investigator Espinosa, Investigator tHlster, Investigator

~~~ 1 0/29/2012

Edith N, Gonzalez, I nvestigator

fOil..\1 fDA ~83 (09/0SJ PREVIOUS EDITIOX OBSOlETE lNSl'tCTlONAL OBSERVATIONS PAGE 6 Ol' II PAGES

Salmonella was detected in peanut and nut butters between 2009 and 2012.

B. Th- brand packaging equipment in the small packaging room of the Peanut Plant is not effectively cleaned between raw and roasted peanuts. Cleaning consists of wiping off non-food contact surfaces with dry paper towels, sweeping underneath and around equipment, as well as vacuuming excess dust.

C. - tote mesh bags utilized by your firm for storing bulk peanuts are not effectively cleaned between storage of raw and treated (roasted and/or brined) peanuts. The tote bags are considered multi-use, and re-used for both raw and roasted peanuts.

i. The totes are cleaned by compressed air to loosen and remove dust/soil. ii. We observed tote bags filled with raw peanuts transported from the Peanut Plant by truck

bed into the raw room of the Peanut Butter Plant. iii. The tote bags are not labeled for raw or roasted peanuts. The tote bags are labeled with

the statement "FOR PEANUTS ONLY".

D. Your firm does not clean production and . .. .. .~ ... . b(4)

Your firm performs allergen testing on finished prod~ct at le~st~and has detected allergens (peanut, almond, and soy) abovelft'l'll,pm m a vanety~ products that do not contain those ingredients on the labeling. ~products were also distributed by your firm. For example,

i. on I 0/31111, peanut allergens greater than ~~~ppm were detected in almond butter afterll - ofproduction ii. on 711_3112, soy allergens were detected in almond butter at. )pm after~f

production iii. onMIW:mond allergens at greater than. ppm wet" detected in peanut butter

after 1 ~ f production

AMENDMENT 1

DEPARTl\IENT OF UEALTII ANL> liUl\IAN SERVICES FOOD AND DRUG AV:VUNISTRATION

DISTRICT ADDRESS AND PHONE NUMBER

6th & Kipling St. {P.O. Box 25087) Denver, CO 80225 - 0087 {303) 236 - 3000 Fax: {303) 236-3100 Industry Information: ~~.fda.gov/oc/industry NAME AtlO TITI.E OF INOMOUAL TO WHOM REPORT ISSUED

TO: Jimmie D. Shearer, President

01\TE{S) OF INSPECTION

09/17/2012 - 10/16/2012* FE! NU~'6ER

1000117188

FIRM NAME

Sunland, Inc . CITY, STATE. ZIP COOE, COUNTRY

Portales, NM 88130

STREET ADDRESS

42593 US Highway 70 TYPE ESTASLISI<MENT INSPECTED

Peanut Butter Manufacturer

E.O.'PLOYEE(S) SIGNATURE DATE ISSUED

Jamie L. C. Dion, Investigator <:J1? Brent w. Higgs, Investigator

SEE REVERSE OF THIS PAGE

Daniel J . Isabel Y. Gloria A.

Lahar, Investigator Espinosa, Investigat or ~lilster, Investigator

~~~ 10/29/2012

Edith t·1. Gonzalez, Investigator

FORM FDA 483 (09108) PREVIOUS ED1TJ0>4 OBSOLETE INSPECTJONAL OOSERVATIONS PAGE 7 OF II PAGES

Additionally, In May 2011, your firm received notification of a complaint that a child experienced ana hylactic shock after ingesting almond butter that contained eanut aller ens.

OBSERVATION 3

Food contact surfaces used for manufacturing low-moisture food were wet at time of use.

Specifically,

On 9/26/12, in the small packaging room of the Peanut Plant, we observed an employee on the­packaging line cleaning a food-contact belt with a spray bottle containing only water. The Peanut Plant Manager stated that the water was to be used on non-food contact surfaces of the packaging equipment.

OBSERVATION 4

The design and workmanship ofequipment does not allow proper cleaning.

Specifically,

B. On 09/25/2012, we observed dead legs on processing equipment in the Peanut Butter Plant: i. A pipe connection approximately three inches long located on the Northwest corner of ~"in-flow" hopper. This connection was not piped to any equipment and was ~ri-clamp and lid, and allows food

ii. A pipe approximately 4 feet long was Production Supervisor explai specific peanut butter products

AMENDMENT 1

DEPAIHMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS AND PHONE NUMBER

6th & Kipling St. (P.O . Box 25087} Denver, CO 80225 - 0087 (303) 236-3000 Fax: (303) 236-3100 Industry Information: www.fda.gov/oc/industry tWI.E AND TITlE OF INDIVIDUAL TO\'IHOM REPORT ISSUED

TO: Jimmie D. Shearer, President FIRM NAME

Sunland, Inc. CITY. STATE. ZoP CODE. COUNTRY

Portales, NM 88130

STREET ADDRESS

42593 US Highway 70 TYPE ESTABLISHMENT INSPECTED

Peanut Butter Manufacturer

OATE(S) OF INSPECTlON

09/17/2012 - 10/16/2012* FEI NUMBER

1000117188

EMPlOYEE{$) SIGNATURE DATE I SSUED

Jamie L. C. Dion, Investigator :.JD­Brent W. Higgs, Investigator Daniel J. Lahar, InvestigatorSEE REVERSE I sabel Y. Espinosa, Investigator .fottC. 10/29/2012

OF THIS PAGE Gloria A. !>lilster, Investigator Edith 1-l. Gonzal ez, Investigator

FOR.'I FDA 483 (09/0S) PRE\~OUSEDmOS OSSOl.ETS INSP.ECTIONAL ODSEin'A TJONS PAGE 8 01' II PAGES

- is not added, nut butter may backflow into the rJP"'IW,ipe extension. iii. A e cont- inin two tri-clamp rings was connected t<~gree pipe connection on

line r.t 'in-flow" pipe. This pipe was not connected to any other nery an a ows ood material to accumulate.

iv. The "T" pipe, connected to the "out-feed" line ofthdDm.ine heat exchanger, ­contains a dead end at the peanut butter flow sensor at~ws food material to accumulate.

v. A pipe conne- proximately 2 inches long was observed located on the retmn pipe connected to th line filler. The connection is closed with a tt·i-clamp and lid and allows food material to accumulate.

vi. The filler hopper contains a pipe connection near the bottom of the hopper. This cotmection is closed with a tri-clamp and lid. Additionally, the firm Production Supervisor stated that the filler has not been used for at least tlu·ee months, but the pipe connector still contained peanut butter.

OBSERVATION 5

Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food pa11icles, dirt, and organic matter and the opp011unity for growth of microorganisms.

Specifically,

A. On 9/25/12, we observe- en weld on the northeast, inner corner of the hopper located at the picking table for the 1 r.1 Line in the Mezzanine of the Mill/Grinding Room of the Peanut Butter Plant. The we was not smooth to facilitate cleaning and sanitizing. Roasted, shelled peanuts fall into the hopper and are transferred to the first floor of the room for addition into peanut butter as needed.

B. On 9/26/12, we observed an uneven weld under the metal cover located after the filler and before the capping machine on the- ine in the Filling/Packaging Room of the Peanut Butter Plant. The weld was not smooth to facilitate cleaning and sanitizing. Open containers with product travel directly under the covers as they are conveyed to the capping machine.

AMENDMENT1

DEPA

Box 25087)

1000117188

President

Inc. 70

Portales NM 88130 Peanut Butter Manufacturer

- 10 16 2012*

Jamie L . C. Dion, Investigator <~ Brent 1'1. Hi ggs, Investi gator

SEE REVERSE OF THIS PAGE

Daniel J. Isabel Y. Gloria A.

Lahar, I nvestigator Espinosa, Investigator .P-11 £ r.1ilster, Investigator

10/29/2012

Edith !•I . Gonzalez, Investigat or

FORM FDA ~83 PREVlOUS EOTT!O~OBSOLETE INSPECTIONAL OBSERVATIONS PAGE 9 OF II PAGeS

C. On 9/27/12, we observed an uneven weld on the northwest, inner corner of the hopper located below the cleaner discharge chute in the Raw Room of the Peanut Butter Plant. The weld was not smooth to facilitate cleaning and sanitizing. Cleaned, shelled peanuts fall into this hopper

OBSERVATION 6

Employees did not wash hands thoroughly in an adequate hand-washing fac ility at any time their hands may have become soiled or contaminated.

Specifically,

A. On 9/17 II 2, we observed an employee in the Mill Room of the Peanut Butter Plant handling and pouring soy protein powder into the production equipment for almond butter. Between handling soy protein powder bags and performing other duties in the Mill Room, he was observed repeatedly wiping his gloved hands on his street clothes. The employee did not wash his hands or change his gloves after wiping his hands on his clothes.

B. The Peanut Plant does not have any hand washing sinks in the production or packaging areas. The building is equipped with hand sanitizer stations in the production and packing rooms.

1. On 9/28/12, we observed five employees having bare hand contact with ready to package, in-shell peanuts in the Picking Room of the Peanut Plant. The closest handwashing sink is located in the employee break room, behind closed doors, and approximately 200-400 feet

from and areas.

OBSERVATION 7

Plumbing is not adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant.

Specifically,

On 9/22/12, during a tour of the Peanut Butter Plant, we observed the three compartment sink in the

AMENDMENT1

DEPAHUI ENT OF HEALTH AND HUI\IAN SEIWICES FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS AND PHONE NUIIBER

6th & Kipling St. {P.O. Box 25087) Denver, co 80225-0087 (303) 236-3000 Fax: {303) 236-3100 Industry Informat ion : www .fda .gov/oc/industry

DATE(S) OF INSPECTION

09/17/2012 - 10/ 16/2 012* f EINUMBER

1000117188

NAI.'E AND TinE OF INDIVIDUAL TO WHOM REPORT ISSUED

TO : Jimmie D. Shearer, President fiRM NAIIE

Sunland, Inc.

STREET ADDRESS

425 93 us Highway 70 CITY, STATE, ZIP CODE, COUNTRY

Portales , NM 88130 TYPE ESTABLISHMENT INSPECTED

Peanut Butter Manufacturer

SEE REVERSE OF THIS PAGE

E~<PLOYEE(S) S!GNATURE

Jamie L. C. Dion, Investigator ~ Bren t 1·1. Higgs, Investigator Dani el J . Lahar, Investigator Isabel Y. Espinosa, Investigator ~L Gloria A. Milster, Investigator Edith t·l. Gonzalez, Investigator

DATE ISSUED

1 0/29/2012

FOR.\1 FDA ~83 (09/08) PREVIOUS EDITIOS OBSOLETE INSPECTIONAL OBSERVATIONS PAGE 10 OF II PAGES

wash room adjacent to the mill room to be leaking, with water accumulating onto the floor and draining towards the floor drain. The floor drain was approximately 15 feet away from the three compartment sink.

OBSERVATION 8

The plant is not constructed in such a matmer as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair.

Specifically,

A. On 9/26/12, we observed a 1x4 inch piece ofwood approximately 1 foot long in a drain located in the middle of the Filling/Packaging Room of the Peanut Butter Plant. The drain is not used and was filled with concrete. The wood was placed vertically along the north end of the drain against the concrete. Wood is not an easily cleanable surface.

B. The walls in the Cleaning Room, Picking Room, and Sheller Room of the Peanut Plant are not easily cleanable. The surface is comprised of "chicken" wire fencing material, and insulation with a plastic overwrap. The walls in these areas were observed with an accumulation of dust, and torn/exposed insulation.

OBSERVATION 9

Failure to store raw materials in a manner that protects against contamination.

Specifically,

A. From 9/17112-10/2112, raw, in-shell peanuts were observed outside in uncovered trailers and open to the elements. Birds too numerous to count were observed flying over, and landing on peanuts in the trailers.

B. On 9/28/12, we observed the weather as overcast and rainy, seven open trailers filled with peanuts were observed stored uncovered on the front ofyour property exposed to moisture from

AMENDMENT1

OEPARHIENT OF II~ALT H AND HUMAN SEHVJCES FOODAND DRUG ADMINISTRATION

OfSTAfCT AOORESS ANO PHOl:E NW! UER

6th & Kipling St . ( P .O . Box 25087) Denver, CO 8022 5 -0087 (303) 236 - 3000 Fax: ( 303) 236-3100 I ndustry Information: \•lww . fda.gov/oc/industry

DATE{$) 0# I~SPECTIOH

09/ 1 7/2012 - 1 0 /16/ 2012* FEl/M.' 8ER

1000117188

IJ.W E AND TITlE OF INDIVIDUAl TOWHOM REPORT ISSUED

TO : Jimmie D. shearer , President 'IRMNAME

Sunland, Inc.

STREET ADDRESS

42593 US Highway 70 CITY, STATE,ZJP CODE, COUNTRY

Portales, NM 88130

TYPE E6TABU SHUENT INSPECTED

Peanut Butter Ma n u f a cturer

the weather.

{), l \\

SEE REVERSE OF THIS PAGE

Elo'PLOYEE(S) SIGNATURE n _ Jami e L . C . Di on, Investigator(PYMt~4f~,f-~ Br ent ~1 . Higgs, I nvest i gator Dani e l J . Lahar, I nve stigator Isabel Y. Espinos a, I nvestigator .k~( "7 f.J---Glori a A. Nilst er, Inve s t i gator {/ Edith 1•1. Gonzalez , Inve s t i ga t o r

DATE ISSUED

10/ 29 / 2 01 2

FORM FD.\ ~83 (09/0S) PRIM OI.i$ EDiliOS OBSOLETE INSP J::C l'JONAL OBSERVATIONS P.\GE II OF II PAGES

OBSERVATION 10

Effective measures are not being taken to exclude pests from the processing areas.

Specifically,

A. On 9/26/12, we observed the Roasting Room roll up door of the Peanut Plant was open to the outside with a plastic strip cmtain hanging down in the door frame. The Peanut Plant ~ explained that the roll-up door remains open during processing, which can be as long ~ per day to allow fork lift access. The roll-up door is approximately 20 feet away from the in-shell peanut roaster oven. The end of the roaster where roasted peanuts are dropped onto a vibrating conveyer is open to the environment.

B. On 9/28/12, we observed one bird-l ike excreta dropping on one pallet of (Product ID 900251) almond butter in 16 oz containers, with manufacture date August 231

d, 20 12 in the Peanut Butter Plant warehouse.

* DATES OF INSPECTION: 09/17/2012(Mon), 09118/20 12(Tue), 09/19/2012(\Ved), 09/20/2012(Thu), 09/2112012(Fri), 09/22/20 12(Snl), 09/23/2012(Sun), 09/24/2012(Mon), 09/25/2012(Tuc), 09/26/20 12(\Ved), 09/27/20 12(Thu), 09/28/20 12(fri), 09/29/2012(Sat), 09/3012012(Sun), I 0/0 112012(Mon), I 0/02/2012(Tue), l0/04/2012(Thu), I0115/2012(Mon), I 0/16/20 12(Tue)

AMENDMENT1