FDA WARNING_LETTER - bB BIOCHEM LABORATORIES INC. - June 15, 2011

The FDA issued a Warning Letter to Biochem Laboratories Inc. on February 17, 2012, following an inspection from May 18 to June 15, 2011. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering clients' drug products adulterated.

Key violations include: 1. **Unsound Test Procedures (21 CFR 211.160(b)):** Deficiencies in spectroscopic (IR) and chromatographic (HPLC) assay procedures led to invalid test results. IR sample spectra lacked active peaks and resembled diluent blanks. HPLC chromatograms showed coeluting peaks, inconsistent standards, and unreliable calculations. The firm's response was inadequate, lacking timelines, assurance of new method accuracy, and evaluation of impact on customer data. 2. **Unvalidated Test Methods (21 CFR 211.165(e)):** The firm failed to establish accuracy, sensitivity, specificity, and reproducibility of test methods. USP monographs used for finished products were not validated for dosage forms, and stability-indicating methods for degradation products were not demonstrated. The firm's response, blaming clients for not validating methods, was deemed insufficient, as the firm is responsible for method validation. 3. **Inadequate Equipment Cleaning and Maintenance (21 CFR 211.67(