FDA 483 - Mayo Clinic Pharmacy - August 15, 2018

On August 15, 2018, the FDA issued a Form 483 to Mayo Clinic Pharmacy, located at 21 2nd St SW, Rochester, MN, following an inspection conducted from August 6-15, 2018. The facility is a producer of sterile and non-sterile products. The report was issued to Kevin R. Dillon, Chief Pharmacy Officer.

The inspection revealed five observations:

1. **Inadequate Product Evaluation for Microbial Contamination:** The firm failed to evaluate and take remedial action when 73 CFUs were found in a viable air sample inside an ISO 5 compounding hood during a 10/30/2017 certification. No identification of CFUs or evaluation of drug impact was conducted.

2. **Non-Microbial Contamination in Production Area:** * On 8/7/2018, rust was observed on cart wheels inside the ISO 7 cleanroom adjacent to an ISO 5 hood during sterile production of amphotericin B 0.15% ophthalmic solution, lot #R1419080718. * On 8/10/2018, duct tape was observed on a power cord on the front right side of an ISO 5 hood during cleaning.

3. **Non-Sterile Disinfecting Agents and Wipes