# FDA 483 - Medical Center Pharmacy, Inc. - April 09, 2020

Source: https://www.globalkeysolutions.net/records/483/medical-center-pharmacy-inc/b9c856a6-c38a-4ce5-abe1-4655261cf553

> FDA 483 for Medical Center Pharmacy, Inc. on April 09, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Center Pharmacy, Inc.
- Inspection Date: 2020-04-09
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Medical Center Pharmacy, Inc. in Cleveland, TN, revealed significant deficiencies in aseptic processing and facility control. Observations included non-microbial and microbial contamination in classified areas, use of non-sterile cleaning agents, and inadequate testing for endotoxins and sterility. The firm also failed to properly segregate hazardous drug production and maintain calibrated equipment, indicating a severe lack of control over sterile drug manufacturing.

## Related Documents

- [483 - 2015-10-13](https://www.globalkeysolutions.net/records/483/medical-center-pharmacy-inc/6f6cc537-950c-479d-b207-784fae9cce00)
- [WARNING_LETTER - 2015-10-13](https://www.globalkeysolutions.net/records/warning_letter/medical-center-pharmacy-inc/fda796a3-fddf-41cb-b835-cb3e2cde1edc)
- [483 - 2020-04-09](https://www.globalkeysolutions.net/records/483/medical-center-pharmacy-inc/90728ad8-dc05-4b36-98ed-eb9c99dedda4)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)
- [June P. Page](https://www.globalkeysolutions.net/people/june-p-page/3b1ffc71-ce2e-47f5-aefe-87fd5eebc792)

Company: https://www.globalkeysolutions.net/companies/medical-center-pharmacy-inc/1250b51e-4839-46c3-aa98-c75c3a3b1e4e

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea