New FDA Warning Letters Show Old Focus on CAPA Remains
The latest group of FDA warning letters, an admittedly small batch, demonstrates that the agency remains fixated on Corrective and Preventive Action (CAPA) plans and related issues.
In 2010, CAPA accounted for the second and fourth most cited issues in FDA observations. In 2011, CAPA-related citations were ranked first and third.
In 2011, medical device firms were issued 175 warning letters, FDA officials say. Of those, 85% had CAPA citations, and 80% had purchase control citations.
See the pattern?
The medical device industry might not, exactly.
We’ve talked to drug and device makers recently who note that when you burrow down into FDA warning letters, it isn’t the agency saying a firm doesn’t have a CAPA program. No, just that the program in place is pretty weak.
Here are the latest enforcement examples coming out of FDA.
A July 16, 2012 letter to Ningbo Huahui Medical Instruments Company Limited in China is a perfect example of what the FDA often finds.
The warning letter in part says that the FDA found, “Failure to adequately verify or validate the corrective and preventive action to ensure that this action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).
For example, the reports for CAPA 2012-2-14 and CAPA 2012-1-05 do not contain evidence to indicate that the corrective actions taken were verified or validated as effective and did not adversely affect the finished device.”
A July 11, 2012 letter to Leisegang Feinmechanik-Optik GmbH in Germany alleged the company, “Does not include the requirements for implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.”
Getting CAPA just right isn’t easy. But getting it wrong can be even harder on your company. The FDA doesn’t show any sign of letting up on CAPA. Wise drug and devicemakers shouldn’t either.