# FDA 483 - CFP Acquisitions Inc. - July 11, 2018

Source: https://www.keypedia.com/records/483/cfp-acquisitions-inc/550f74b4-6e44-4882-af4a-0d4a5076336f

> FDA 483 for CFP Acquisitions Inc. on July 11, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CFP Acquisitions Inc.
- Inspection Date: 2018-07-11
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: On July 11, 2018, the FDA issued a Form 483 to CFP Acquisitions, Inc., a producer of sterile drug products located at 6136 E. 51st St., Tulsa, OK 74135, following an inspection from June 25-29, July 2, 5, and 11, 2018. David K. Johnson, Pharmacist-in-Charge, was the recipient.

The inspection revealed six observations:

1.  **Aseptic Processing Personnel Issues:** Personnel engaged in aseptic processing were observed with exposed skin around the face and with their face and exposed skin inside the ISO 5 hood. Specifically, a technician was observed on June 26 and 27, 2018, preparing sterile drug preparations in an ISO 5 laminar flow hood with exposed skin (forehead, eyes, and side of cheeks). Additionally, the technician did not sanitize the second pair of sterile gloves after donning. This affected Lot #06262018@1 of Tri-Mix and Lot #s 06272018@5, #06272018@6, and #06272018@7 of Papaverine/Phentolamine and Tri-Mix products.

2.  **Inadequate Media Fills:** Media fills

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## Related Officers

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

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

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9