OPS International Inc – FDA 483, Mar 2, 2022

The FDA Form 483 details multiple deficiencies at an unnamed outsourcing facility.

**Quality Control and Product Release:** * **Out-of-Specification (OOS) Products Released:** 59 lots of drug products with OOS potency/reconstitution time were released between January 1, 2021, and February 16, 2022, with 11 lots still on the market. * **Inadequate Quality Control Unit:** The quality control unit failed to reject procedures or specifications impacting drug product quality. * **Deviation Management Failure:** The firm failed to thoroughly review unexplained discrepancies and batch failures, not following its "Deviation Management" SOP, which requires evaluating impact on product safety, identity, strength, quality, and purity, and investigating other affected batches.

**Aseptic Processing and Environmental Control:** * **Microbiological Recoveries:** Approximately 185 microbiological recoveries were identified from personnel and environmental sampling in the ISO 5 environment during production from July 2021 to February 2022. * **Environmental Monitoring Deficiencies:** The SOP for environmental monitoring is inadequate, failing to identify critical sampling locations within the ISO 5 LAFW during filling, and lacking scientific justification for omitting product contact surface sample sites (e.g., filling needle, hopper). * **Air Supply and Pressure Control Issues:** Deviation #D-2021-007