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Calibration and Lessons learned from FDA Warning Letters

Posted by Phil Wiseman on Aug 13, 2015 8:00:00 AM
Phil Wiseman
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P.T. Barnum is credited with saying- All Press is Good Press.

 

 If you have received an FDA Form 483 warning letter, you may disagree with that statement.

If you have not made 21 CFR part 111, 21 CFR part 211 and 21 CFR part 820  your best friend, then I suggest you download them now.

Click the link below to access:FDA Logo

21 CFR 

 A paper was recently presented at the NCSL International Conference- Measurement Science and The Quality of Life- regarding FDA Warning Letters- 483's- and calibration.

Form 483's are public knowledge and accessible via the internet to anyone who wants to see.  You don't want to lose credibility with your customers or have your company stock devalued by the ramifications of an FDA warning letter.

 

The paper " Best Lessons Learned from FDA Warning Letters" presented by Walter Nowocin of Medtronic, Inc. at the NCSL International Conference reviewed CALIBRATION related issues articulated in FDA Form 483 Warning Letters.

If the FDA is going to look at your calibration program, maybe you should look at it first!

The FDA only issues warning letters for violations of regulatory significance.

 

 

 


 

Learn from the mistakes of others.

Some common themes were present in a review of the Form 483's issued regarding calibration.

  • Lack of understanding of the difference accuracy and resolution
  • Failure to secure Electronic Data
  • Verifying and NOT Calibrating- there is a difference
  • Lack of Adequate Procedures
  • Not following Procedures
  • Not applying Calibration Traceability
  • Improper Validation of Software
  • Disregarding Out Of Specification results

 



Don't make the same mistakes.

 Download the "Best Lessons Learned from FDA Warning Letters" whitepaper

 

Visit our International Standards used in Calibration page for more on standards used in calibration.


 

Topics: Standards and Compliance

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