The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic,...
-
Upload
cecily-mckinney -
Category
Documents
-
view
217 -
download
0
Transcript of The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic,...
![Page 1: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/1.jpg)
The Top 10 List – Best Lessons Learned from FDA Warning
Letters
Walter NowocinMedtronic, Inc./Minneapolis, MinnesotaMeasurement Science Conference
23 March, 2012
![Page 2: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/2.jpg)
Objectives
Review metrology related warning letters over the past five years – the best of the best
Have discussions involving best practices on avoiding similar occurrences
Pass along lessons learned Learn about new FDA search site
![Page 3: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/3.jpg)
Source of Data
All data in this presentation was taken from the ‘FDA Electronic Freedom of Information Reading Room – Warning Letter and Responses’
http://www.fda.gov/foi/warning.htm
In the past I used the FDA site to search the past twelve months of warning letters containing the words calibrate, calibrated, or calibration.
For example in 2010, I searched a total of 437 warning letters with 15 having calibration issues.
![Page 4: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/4.jpg)
FDA Warning Letter Search Site
http://www.fda.gov/foi/warning.htm
![Page 5: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/5.jpg)
FDA Form 483 ‘Reading Room’
http://www.fda.gov/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/default.htm
www.fda.gov/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/default.htm
![Page 6: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/6.jpg)
General Observations
Over five years, warning letters have increased while calibration specific issues have decreased.
Calibration issues tend to be basic; i.e. past due dates, no procedures, etc.
If there are calibration issues, they are usually associated with many other quality system issues. Rarely a warning letter just for calibration.
Most violations are to company specific requirements and not FDA requirements.
![Page 7: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/7.jpg)
FDA Warning Letter Categories Quality System Regulation - 820 Medical Devices
Current Good Manufacturing Practice – Finished Pharmaceuticals
Good Laboratory Practice Regulations - Nonclinical Laboratory Studies
Current Good Manufacturing Practice – API (Active Pharmaceutical Ingredient)
FDA 501k Product Approval Process
![Page 8: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/8.jpg)
820.72(a) – No Annual Cal; Failed on Demo of Cal – 7 Jan 08
Number 10
![Page 9: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/9.jpg)
501(a)(2)(B) – Incorrect Use of ‘N/A’ – 28 April 2008
Number 9
![Page 10: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/10.jpg)
820.70(i) Failure to Validate Computer Software – 25 Mar 2008
Number 8
![Page 11: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/11.jpg)
cGMP for API – Failed to Calibrate within Intended
Range (7 April 2011)
Number 7
![Page 12: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/12.jpg)
820.72 (b) – Cal Procedures; Accuracy and Precision (18 Sep 08)
Validation of Heat Sealer
No Calibration of Temperature Gauges for monitoring heat sealer
Number 6
![Page 13: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/13.jpg)
211 – Overdue Cal Trending (23 Dec 09)
What Calibration Metrics are you monitoring for quality trends?
Do you have established ‘trigger’ points for investigation action?
Number 5
![Page 14: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/14.jpg)
211.192 – Out of Specification Investigation (22 Apr 09)
Analytical Lab finding, but is a lesson learned for Cal Labs.
Number 4
![Page 15: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/15.jpg)
820.72(b)(1) – Traceability to Reference Standard – 8 Dec 06
Number 3
![Page 16: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/16.jpg)
211.68 – Original Calibration Data (7 May 09)
Number 2
![Page 17: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/17.jpg)
820.72(b)(2) – Self Calibration Program (26 Feb 09)
Number 1
![Page 18: The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23.](https://reader035.fdocuments.us/reader035/viewer/2022062715/56649dad5503460f94a9c95f/html5/thumbnails/18.jpg)
Any questions on these warning letters or Form 483s?