# FDA 483 - Overton Brooks VA Medical Center - February 03, 2020

Source: https://www.keypedia.com/records/483/overton-brooks-va-medical-center/2dc6bd27-f163-470a-84ea-81e907734166

> FDA 483 for Overton Brooks VA Medical Center on February 03, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Overton Brooks VA Medical Center
- Inspection Date: 2020-02-03
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Overton Brooks VA Medical Center in Shreveport, LA, revealed significant deficiencies in their sterile drug product manufacturing operations. The facility's ISO 5 classified aseptic processing areas were located within unclassified rooms, and critical procedures like antechamber disinfection and continuous HEPA filtered air flow were not maintained. Additionally, equipment placement and overall facility design in segregated compounding areas were found to be unsuitable, posing risks to product sterility.

## Related Documents

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## Related Officers

- [Brandon C. Heitmeier](https://www.keypedia.com/people/brandon-c-heitmeier/09e1b64b-01de-4f8b-819a-1179d8b4c0c1)
- [June P. Page](https://www.keypedia.com/people/june-p-page/3b1ffc71-ce2e-47f5-aefe-87fd5eebc792)

Company: https://www.keypedia.com/companies/overton-brooks-va-medical-center/e0aaed00-95ee-4850-9429-20f0dee8b22d

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