FDA WARNING_LETTER - BIO LAB-ST. JOSEPH CORP - March 01, 2011

On April 19, 2011, the FDA issued a Warning Letter to BIO LAB-ST. JOSEPH CORP following an inspection from February 2 to March 1, 2011, at their Bayamon, PR facility. The inspection determined that the firm manufactures Class II culture media devices, which were found to be adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods and controls did not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Production Process Control (21 CFR § 820.70(a)):** Failure to ensure devices conform to specifications, evidenced by a sterilizer failure in January 2010 affecting 136 lots of culture media, and inadequate cleanroom control measures (e.g., insufficient monitoring, lack of air handling unit filters, unvalidated air duct sanitization). 2. **Process Validation (21 CFR § 820.75(a)):** Failure to validate moist sterilization and sealing processes. 3. **Complaint Handling (21 CFR § 820.198(a), (c)):** Repeat deficiency from 2008; inadequate procedures for receiving, reviewing, and investigating complaints, with approximately