FDA WARNING_LETTER - Greer Laboratories Inc - November 15, 2013

The FDA issued a Warning Letter to Greer Laboratories, Inc. on April 21, 2014, following an inspection from November 5-15, 2013. The inspection revealed significant deviations from current Good Manufacturing Practice (CGMP) requirements for licensed allergenic extracts, which are biological drug products. These violations contravene Section 501(a)(2)(B) of the FD&C Act, the company's Biologics License Application (BLA) under Section 351(a) of the PHS Act, and 21 CFR Parts 210, 211, and 600-680.

Key violations include: 1. **Unlicensed Custom Mixtures:** Manufacturing and distributing allergenic "custom mixtures" without obtaining a license, as required by 21 CFR 610.17. 2. **Inadequate In-Process Controls:** Failing to establish and follow written procedures for in-process controls, such as decanting bulk extract without subsequent testing for uniformity and homogeneity, and without quality control unit review (21 CFR 211.110(a)). 3. **Insufficient Environmental Monitoring:** Inadequate monitoring of viable organisms in the aseptic filling suite, including insufficient air sampling and lack of settling plates during filling operations (21 CFR 211.42(c)(10)(iv