FDA 483 - Hikma Injectables USA Inc - June 08, 2022

During an inspection conducted from May 23, 2022, to June 8, 2022, the U.S. Food and Drug Administration (FDA) identified significant concerns at Hikma Injectables USA Inc., an outsourcing facility in Dayton, NJ. The FDA 483 document outlines deficiencies primarily related to the company's sterile drug manufacturing processes, indicating a need for improved adherence to good manufacturing practices. Key issues included inadequate environmental monitoring in aseptic processing areas. Specifically, the firm did not provide scientific justification for the frequency, duration, or positioning of airborne particulate monitoring during sterile operations, nor did they consistently monitor to required air classifications. Additionally, the location for viable environmental monitoring lacked scientific justification. Another critical observation involved the air supply filtration in aseptic processing areas. The company failed to adequately evaluate airflow patterns in all critical ISO 5 Laminar Flow Hoods under conditions that simulate actual production, with specific products being manufactured without such direct assessment. Furthermore, airflow studies did not account for occupied cleanroom conditions. Lastly, the inspection revealed an inadequate stability program for drug products. Hikma Injectables USA Inc. based its product expiration dates on data from products manufactured at other facilities, rather than performing direct stability testing, including container closure integrity, on products produced at their Dayton site. The company is expected to address these observations to ensure the quality and sterility of its drug products.