Laboratorio Magnachem International – FDA Warning Letter, Nov 10, 2023

The FDA issued a Warning Letter to Laboratorio Magnachem International following a November 7-10, 2023, inspection, citing significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. Additionally, five Broncochem products (Kids COLD & FLU SYRUP, COLD & FLU CAPLETS, EXPECTORANT SYRUP, Kids MAXIMUM COUGH, and MAXIMUM COUGH) are deemed unapproved new drugs and misbranded.

Key violations include: 1. **Inadequate OOS Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate OOS stability results and missing stability intervals, such as failing phenylephrine assays for Broncochem Kids Cold and Flu Syrup. Their response, attributing issues to storage and unvalidated methods, was inadequate, lacking root cause analysis, CAPA, and risk assessment for distributed products. 2. **Insufficient Laboratory Controls (21 CFR 211.160(b)):** The firm lacked adequate microbiological test methods for objectionable microorganisms, microbial counts, and Burkholderia cepacia complex, and failed to provide sufficient evidence of method validation. Concerns were also raised regarding the testing of glycerin for diethylene glycol (DEG) contamination. 3. **Inadequate Computer System Controls (21 CFR 211.68(b)):** Laboratory equipment lacked restricted access, unique user credentials, and proper data backup, allowing unauthorized deletion