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

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