# FDA 483 - CFP Acquisitions Inc. - December 08, 2022

Source: https://www.globalkeysolutions.net/records/483/cfp-acquisitions-inc/87a6f235-4b88-4552-8fbb-f095a670cff7

> FDA 483 for CFP Acquisitions Inc. on December 08, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: CFP Acquisitions Inc.
- Inspection Date: 2022-12-08
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations II
- Summary: CFP Acquisitions, Inc. in Tulsa, OK, a producer of sterile drug products, was cited for significant deficiencies in quality control and aseptic processing during an FDA inspection. Observations included releasing sub-potent drug product, inadequate cleanroom design, lack of dynamic smoke studies, use of non-pharmaceutical grade components, and insufficient media fill simulations. These issues indicate a serious lack of control over critical manufacturing processes.

## Related Documents

- [483 - 2015-07-23](https://www.globalkeysolutions.net/records/483/cfp-acquisitions-inc/9ef9d19e-4bd1-4e34-8497-c08f562bba4a)
- [483 - 2018-07-11](https://www.globalkeysolutions.net/records/483/cfp-acquisitions-inc/550f74b4-6e44-4882-af4a-0d4a5076336f)
- [483 - 2022-01-18](https://www.globalkeysolutions.net/records/483/cfp-acquisitions-inc/6a3f1c7d-2931-494b-a015-f1affe552bab)

## Related Officers

- [Margaret M. Annes](https://www.globalkeysolutions.net/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.globalkeysolutions.net/companies/cfp-acquisitions-inc/27cf9a06-4a99-40fd-adff-e6ca4e741871

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-ii/930d696b-0ac7-4de4-8268-e3db00525bc6