FDA 483 - CFP Acquisitions Inc. - January 18, 2022

This FDA Form 483 document details inspectional observations at CFP Acquisitions, Inc., a producer of sterile drug products located at 6136 E. 51st St., Tulsa, OK 74135 (FEI Number: 3001576820). The inspection was conducted on multiple dates: November 10, 12, 15, 17, 2021; December 3, 8, 2021; and January 18, 2022. The report is issued to Thomas J. Marti, President.

Five observations were noted:

1. **Drug Product Strength Discrepancy:** The firm released Lot #09082021@1 of Methylcobalamin 5000mcg/mL Injectable with a potency of 89.3%, which was below specifications. The product was distributed, and customers were advised to increase the administered dose. The Formula Worksheet lacked documentation of the exact number of vials filled for this lot. 2. **Cleanroom Air Return Design Flaw:** The ISO 7 Buffer Room and ISO 8 Ante Room have HEPA filters directly adjacent to ceiling-level air returns, preventing proper air circulation and effective dilution of particle-laden air. 3. **Lack of ISO 5 Area Certification:** Routine and rigorous certification, including