Sure-Biochem Laboratories, LLC – FDA Warning Letter, Oct 7, 2022

The FDA issued Warning Letter #646619 to Sure-Biochem Laboratories, LLC, a contract testing laboratory, following an inspection from September 28 to October 7, 2022. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering the drugs tested by the firm adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Laboratory Controls (21 CFR 211.160(a) and 211.160(b)):** The firm failed to adequately establish and follow procedures for growth promotion testing of microbiological media, including insufficient challenge conditions and acceptance criteria. For example, a Salmonella media lot was accepted despite exhibiting light/moderate growth of *Escherichia coli*, which should have been inhibited. The firm also failed to conduct growth promotion for each lot of media received. Additionally, alternative microbial methods used for drug product testing were not validated to ensure they were equivalent to or better than USP methods, failing to reliably detect objectionable microorganisms like *Burkholderia cepacia complex* (Bcc). The firm's response was inadequate as it did not address reviewing the validity of previous results or communicating with clients about potentially non-compliant analyses. 2. **Inadequate Quality Unit (21 CFR 211.22(a) and 211