FDA 483 - Velocity Pharma LLC - December 14, 2023

An FDA inspection conducted between November 3, 2023, and December 14, 2023, identified significant compliance deficiencies at an unnamed pharmaceutical firm. The observations, documented in an FDA Form 483, highlight critical issues in quality control, product storage, and distribution practices, indicating potential violations of the Federal Food, Drug, and Cosmetic Act. A primary concern (Observation 1) was the inadequacy of the firm's quality control unit. It lacked essential procedures for verifying the reliability of Certificates of Analysis from Contract Manufacturing Organizations (CMOs) for imported sterile ophthalmic drugs and other products. Furthermore, there was no formal quality agreement or oversight process for third-party auditors assessing CMO compliance, nor a procedure to confirm that drugs labeled USP (e.g., Levocetirizine Dihydrochloride Tablets USP) met corresponding monograph standards. Observation 2 noted that drug products were not stored under appropriate temperature and humidity conditions. A crucial deficiency was the incomplete warehouse temperature mapping study, which failed to assess worst-case summer conditions or demonstrate HVAC system efficacy during cold temperatures. Additionally, the firm failed to maintain complete distribution records (Observation 3), lacking details such as dosage form, consignee information, shipment dates, quantities, and lot numbers for various drug products. This directly impacted the firm's ability to establish a readily traceable system for product recalls (Observation 4). The existing recall procedure was found to be insufficient, lacking vital components like health hazard evaluations, clear FDA notification protocols, detailed recall plans for consignees, and effectiveness checks. The firm is required to address these observations to ensure compliance with regulatory standards.