FDA WARNING_LETTER - Cephazone Pharma LLC - August 26, 2010

On April 25, 2011, the FDA issued a Warning Letter to Cephazone Pharma, LLC, following an inspection from July 12 to August 26, 2010, which identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211). These violations render the firm's drug products adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Sterility Testing (21 CFR § 211.167(a)):** The firm used insufficient beta-lactamase neutralizing agent for sterility testing of Ceftriaxone and failed to include *Escherichia coli* as a test organism, despite its protocol. The firm's response lacked scientific data to justify the correlation between the neutralizer amount and drug product. 2. **Lack of Microbiological Contamination Prevention Procedures (21 CFR § 211.113(b)):** Environmental monitoring, disinfection, and process simulation media procedures were not validated to demonstrate the effectiveness of neutralizing agents against cephalosporins. The firm's response was inadequate as it did not provide scientific rationale or study data. 3. **Insufficient Specifications and Test Procedures (21 CFR § 211.160