Hikma Pharmaceuticals USA INC. – FDA EIR, Nov 22, 2019

An FDA Good Manufacturing Practices (GMP) surveillance and for-cause inspection was conducted at Hikma (West Ward Columbus Inc.) in Columbus, OH, from November 13 to November 22, 2019. The inspection focused on the company's manufacturing, packaging, and distribution of various pharmaceutical products, including opioid oral liquid and solid dosage forms. Notably, no FDA Form 483, Inspectional Observations, was issued at the close of the inspection, indicating the absence of official violations requiring a formal response. However, four significant issues were discussed with management. These included inadequate labeling of a bulk morphine sulfate holding tank, a leak observed from a morphine sulfate filling apparatus, leaking filling tubes on a packaging line also handling morphine sulfate, and two laboratory stock solutions with incorrect or expired dating. The company's management acknowledged these observations and committed to immediate corrective actions. Several voluntary corrections were promptly implemented during the inspection, such as retraining employees on proper tank labeling, revising work instructions to address leaks during filling, and correcting the inaccurate expiry dates on the laboratory stock solutions. Furthermore, the inspection confirmed that two observations from a previous 2019 GMP inspection—failures in deviation investigation procedures and uncontrolled access to labeling materials—had been successfully rectified, demonstrating Hikma's commitment to continuous improvement in regulatory compliance under Good Manufacturing Practices.