Pharmedium Services, LLC – FDA 483, Apr 11, 2018

This FDA Form 483 details significant deficiencies in the firm's quality system and manufacturing operations across multiple facilities (Memphis, Cleveland, MS, Sugar Land, TX, Dayton, NJ) from January 1, 2017, to January 3, 2018.

**Key Violations and Observations:**

* **Lack of Notification for Investigations:** Procedures for notifying responsible officials (e.g., Corporate VP of Quality) of investigations (Nonconformance, OOS, CAPA, complaints) are not followed. Examples include suspected sterility failures and confirmed endotoxin OOS results where the Corporate Quality Unit was not routinely informed. * **Failure to Follow Quality Control Unit Procedures and Data Integrity Issues:** The Corporate Quality/Compliance Unit failed to follow written procedures (CPS-086, CPS-080) for oversight. * Compliance/Management Reviews were not conducted or lacked proper documentation (summarized conclusions, meeting minutes). * Meeting minutes were unsecured, incomplete, and lacked data integrity controls (handwritten, stored on personal laptops without controls). * The Chief Compliance Officer did not receive or review required meeting minutes. * **Incomplete Investigation Records:** Approximately 630 confirmed Out-of-Specification (OOS) investigations lacked conclusions or follow-up, with many significantly past due (e.g., 157 days for Hydromorphone OOS