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# CFP Acquisitions FDA-483
- URL: https://www.fdaweb.com/cfp-acquisitions-fda-483/
- Published: 2022-06-02T12:00:00.000Z
- Updated: 2026-09-14T17:47:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151956

FDA has released the FDA-483 issued following a multi-day inspection between 11/10/21 and 1/8/22 at CFP Acquisitions, a Tulsa, OK, producer of sterile drug products. The inspection observations were:

- releasing drug product in which the strength differs from that it purports or is represented to possess;
- cleanrooms are outfitted with HEPA filters directly adjacent to the return vent in the ceiling;
- there is a lack of routine and rigorous certification of the ISO 5 area, including smoke studies performed under dynamic conditions;
- using a non-pharmaceutical grade component in the formulation of a drug product; and
- media fills are not performed to closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.