High frequency of CAPA related observations in Warning Letters.

Posted on July 18, 2013

Globiox proactively monitors FDA inspection trends by reviewing and analyzing the contents of the Warning Letters. A current trend we detected is the high frequency of observations related to Corrective and Preventive Actions (CAPA) in Warning Letters. Out of 43 Warning Letters issued to Medical Device companies (since March 22, 2013), 29 have contained observations relating to Corrective and Preventive Actions (CAPA) deficiencies 21 CFR 820.100. Of these 29 Warning...

FDA 483: Does your business contain critical errors?

Posted on August 22, 2012

In the aftermath of an FDA site inspection resulting in unsatisfactory findings, the company in question faces a difficult situation that must be addressed quickly to avoid serious consequences. If not properly addressed, negative observations made during an FDA visit can ultimately result in suspended operations, bad press, scrupulous monitoring of operations, recall of products, and warning letters. Fortunately, the process followed by the FDA is intended to allow most companies operating out of compliance to remediate their practices and continue operation in an acceptable manner. Although the remediation process tends to be hectic and unpleasant, it can actually be beneficial for a company because if done correctly, the remediation will result in higher quality business practices.

At the conclusion of an FDA site visit, the inspectors will issue an FDA Form 483 if there are observations. A 483 lists detailed observations of any issues the inspectors consider...