# FDA 483 - Overton Brooks VA Medical Center - December 18, 2024

Source: https://www.keypedia.com/records/483/overton-brooks-va-medical-center/09d9357d-b5d5-4dee-bad7-f2a7699fdfe8

> FDA 483 for Overton Brooks VA Medical Center on December 18, 2024. Product: Other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Overton Brooks VA Medical Center
- Inspection Date: 2024-12-18
- Product Type: Other
- Summary: An FDA inspection of Overton Brooks VA Medical Center, a producer of sterile and non-sterile products in Shreveport, LA, was conducted from December 10-18, 2024. The inspection revealed three observations.

Observation 1: Hazardous drugs were produced without adequate containment, segregation, and/or cleaning to prevent cross-contamination. Specifically, on December 11, 2024, a pharmacist retrieved a Fluorouracil vial from a hazardous waste bin, wiped it, and attempted to use it for production. The pharmacist did not perform decontamination and deactivation cleaning steps in the ISO-5 work area after retrieving the vial. The drug product was subsequently remade and administered to an immunocompromised veteran.

Observation 2: Personnel infrequently changed and sanitized gloves, leading to potential contamination. Multiple instances were observed on December 11, 2024, in the chemo buffer room:
- A pharmacist returned to the ISO-5 hood without sanitizing gloved hands after disposing of vials and components.
- A pharmacist removed hands from the ISO-5 environment to verify a label and returned without sanitizing.
- A pharmacist adjusted their face mask twice and returned to the ISO-5 hood without sanitizing gloves.
- A pharmacist picked up a fallen shoe cover from the floor, then touched a pass-through door and returned to the ISO-5 environment without sanitizing or changing gloves.
- During glove changes, the pharmacist

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- [483 - 2017-02-17](https://www.keypedia.com/records/483/overton-brooks-va-medical-center/8f097a0b-5095-4195-9a5b-d3e73f0632ff)
- [483 - 2020-02-03](https://www.keypedia.com/records/483/overton-brooks-va-medical-center/2dc6bd27-f163-470a-84ea-81e907734166)
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## Related Officers

- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)

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