FDA 483 - Hikma Injectables USA Inc - August 08, 2025

The FDA conducted an inspection of Hikma Injectables USA Inc., an outsourcing facility located in Dayton, NJ, from July 28 to August 8, 2025. The inspection revealed several critical compliance issues under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Key violations included inadequate written procedures for production and process controls, particularly concerning the visual inspection of compounded sterile products. The firm"s Standard Operating Procedure (SOP) allowed a high percentage of defects before initiating quality investigations, lacking scientific justification and clarity on defect classifications. A specific incident involved a Ketamine HCL batch with a 24.4% rejection rate due to overfilled syringes, highlighting procedural deficiencies.

Additionally, the facility"s equipment and utensils were not properly cleaned and maintained, as evidenced by black discoloration on the interior of a HEPA bracket used in sterility testing. The aseptic processing areas were also found deficient in environmental monitoring, with air sampling not representative of the full production duration.

Moreover, procedures to prevent microbiological contamination were inadequate. The firm"s testing protocol allowed multiple failed tests before initiating an investigation, as seen with Rocuronium Bromide, where a tubing leak was identified as the root cause of repeated test failures.

The FDA requires Hikma Injectables USA Inc. to address these issues promptly, ensuring compliance with established regulations to maintain product safety and quality. The firm is expected to revise its SOPs, enhance equipment maintenance, and improve environmental monitoring and contamination prevention measures.