Superstat Corp – FDA Warning Letter, May 3, 2011

On August 5, 2011, the FDA issued a Warning Letter to Superstat Corporation following an inspection from March 7 to May 3, 2011, which found their Superstat Modified Collagen Hemostatic Sponges to be adulterated. The inspection revealed non-conformity with Quality System (QS) regulation (21 CFR Part 820) and a lack of an approved Premarket Approval (PMA) application.

Key violations include: 1. **Process Validation (21 CFR 820.75(c)):** Failure to revalidate the sterilization process after a 2005 packaging change. The firm's response regarding revalidation and risk assessment was deemed inadequate due to lack of supporting data. 2. **Process Control (21 CFR 820.75(b)):** Failure to implement procedures for monitoring sterilization process parameters, specifically lacking documentation of required bioburden testing from 2005-2009. 3. **Design Changes (21 CFR 820.30(i)):** Absence of established design change procedures prior to the 2005 packaging change, lack of validation for indefinite shelf life of packaging material, and no risk analysis or Design History File for this change. 4. **Corrective and Preventive Action (21 CFR 820.100(a)):**