# FDA 483 - Mayo Clinic Pharmacy - August 15, 2018

Source: https://www.keypedia.com/records/483/mayo-clinic-pharmacy/ae89ec4a-91a3-4725-ae4f-e823f6f342f0

> FDA 483 for Mayo Clinic Pharmacy on August 15, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mayo Clinic Pharmacy
- Inspection Date: 2018-08-15
- Product Type: Drugs
- Office Name: Minneapolis District Office
- Summary: 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

## Related Documents

- [483 - 2018-08-15](https://www.keypedia.com/records/483/mayo-clinic-pharmacy/986e873a-a7ee-4bfa-8cd6-e5a9680f8fb6)
- [483_RESPONSE - 2018-08-10](https://www.keypedia.com/records/483_response/mayo-clinic-pharmacy/14772710-9a0c-413d-9de5-89d7cdcf934c)
- [STATE_REFERRAL_LETTER - 2018-08-10](https://www.keypedia.com/records/state_referral_letter/mayo-clinic-pharmacy/7fe799d0-e6bf-4094-8c44-a8efa1211fbd)

## Related Officers

- [Performance Improvement Coordinator](https://www.keypedia.com/people/tenzin-jangchup/733eb315-0eeb-40ce-af6d-03b406a9235d)
- [Deputy Commissioner for Foods](https://www.keypedia.com/people/james-k-ireland/78658286-3e62-4069-a8e1-b157aa77c7fe)

Company: https://www.keypedia.com/companies/mayo-clinic-pharmacy/fb0699ba-f561-46a6-a62c-75da4edf1733

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d