FDA WARNING_LETTER - AMMAN PHARMACEUTICAL INDUSTRIES - August 15, 2023

The FDA issued a Warning Letter to Amman Pharmaceutical Industries (FEI 3013501887) following an inspection from August 7-15, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Facility and Equipment Design (21 CFR 211.42(c)(10)):** Aseptic processing areas had fundamental design flaws, such as exposed product, inadequate hopper covers, and sterile tubing contacting non-sterile surfaces, compromising aseptic conditions. 2. **Inadequate Monitoring of Aseptic Processing:** The firm failed to ensure adequate environmental monitoring, with over 50 microbial excursions observed despite claims of no issues. Data integrity breaches compromised the reliability of test results, and environmental isolate identification was insufficient. 3. **Failure to Prevent Microbiological Contamination (21 CFR 211.113(b)):** The firm shipped sterile products to the U.S. without conducting process simulations (media fills) or adequately documenting operator interventions. Poor aseptic technique and insufficient sterilization of equipment directly contacting sterile product constituents were also observed. 4. **Incomplete Laboratory Records (21 CFR 211.194(a)):** Laboratory records lacked complete and trustworthy data, with evidence of overwritten, discarded, and unrecorded data, compromising