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

Source: https://www.globalkeysolutions.net/records/483/mayo-clinic-pharmacy/986e873a-a7ee-4bfa-8cd6-e5a9680f8fb6

> 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: An FDA inspection of Mayo Clinic Pharmacy in Rochester, MN, a producer of sterile and non-sterile products, revealed significant deficiencies in aseptic processing and contamination control. Observations included inadequate evaluation of microbial contamination in ISO 5 areas, presence of non-microbial contamination, use of non-sterile disinfectants, and insufficient disinfectant contact times. Additionally, the firm failed to perform endotoxin testing for certain multi-dose sterile products.

## Related Documents

- [483_RESPONSE - 2018-08-10](https://www.globalkeysolutions.net/records/483_response/mayo-clinic-pharmacy/14772710-9a0c-413d-9de5-89d7cdcf934c)
- [STATE_REFERRAL_LETTER - 2018-08-10](https://www.globalkeysolutions.net/records/state_referral_letter/mayo-clinic-pharmacy/7fe799d0-e6bf-4094-8c44-a8efa1211fbd)
- [483 - 2018-08-15](https://www.globalkeysolutions.net/records/483/mayo-clinic-pharmacy/ae89ec4a-91a3-4725-ae4f-e823f6f342f0)

## Related Officers

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

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

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