FDA 483 - United Pharmacy - August 18, 2017
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On August 14-18, 2017, the FDA inspected United Pharmacy, LLC, a producer of sterile and non-sterile drug products in West Palm Beach, FL. The inspection, led by Drug Investigator Jessica L. Pressley, resulted in eight observations cited to Mina M. Banoub, Pharmacist in Charge.
Key observations include:
1. **Microbial Contamination and Inadequate Investigation:** Actionable microbial contamination (Aspergillus versicolor) was found in the ISO 5 area on November 29, 2016. The firm attributed the Out of Specification (OOS) result to the vendor without supporting evidence and released six batches of sterile products (Testosterone Cypionate, Testosterone pellets, HCG injections) between November 30 and December 15, 2016, based solely on passing sterility tests.
2. **Substandard Drug Product Release:** The firm released Testosterone 50mg subcutaneous pellets (lot # PT50-2) despite receiving multiple failing potency test results (83.4%, 86%, 78.3%) from a contract lab. A fourth test yielded a passing result (96.2%), but the firm failed to investigate the three OOS results or provide scientific rationale for invalidating them before shipping the product.
3. **Improper Gowning Procedures:** On August 16, 2017, operators
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