Hikma Pharmaceuticals USA Inc. – FDA 483, Jun 12, 2024

From May 29, 2024, to June 12, 2024, the FDA inspected Hikma Pharmaceuticals USA Inc., an outsourcing facility located at 2 Esterbrook Ln, Cherry Hill, NJ. The inspection report, issued to General Manager Omar F. Alkhrisat, detailed three observations.

Observation 1 noted that procedures to prevent objectionable microorganisms in non-sterile drug products were not established and followed. Specifically, air visualization "smoke" studies (TestProtCHH15017 and TestProtCHH15372) for Room 115 revealed deficiencies. Dynamic operations like changing settle plates, refilling stoppers, and clearing jams were not included in TestProtCHH15017, and the smoke visualization was difficult to see. Additionally, the studies' length, smoke volume, and camera angles were insufficient to fully visualize air flow under dynamic conditions.

Observation 2 indicated that laboratory controls lacked scientifically sound and appropriate test procedures to assure drug product quality. The firm's co-validated method transfer report (ReportCHH15181) for Fentanyl in Fentanyl Citrate in 0.9% Sodium Chloride Injection IV Bags (SOPCHH15817/TMD227) omitted established method validation characteristics such as accuracy and instrument comparability. The co-validation was performed in the firm's R&D laboratory, while