# FDA 483 - East Orange VA Medical Center - April 29, 2025

Source: https://www.keypedia.com/records/483/east-orange-va-medical-center/8d641a12-3c86-4e95-8e55-bb2e2bf9b237

> FDA 483 for East Orange VA Medical Center on April 29, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: East Orange VA Medical Center
- Inspection Date: 2025-04-29
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of East Orange VA Medical Center, a producer of sterile products, was conducted from April 22-29, 2025. The inspection, led by Investigator Logan T Williams, identified three observations related to facility conditions and manufacturing practices.

Observation 1 noted that production areas had difficult-to-clean or porous, particle-generating, or visibly dirty equipment/surfaces. Specifically, rust was found on a workbench table in the Segregated Compounding Area (SCA) (room -202A), approximately two feet from the ISO-5 Sterile Compounding area. Discoloration was observed on a HEPA pre-filter below an air return vent in the SCA. Additionally, puddled liquid was found in a cabinet within a closet adjacent to the SCA (room -167), which contained cleaners and a handwashing sink used prior to production.

Observation 2 highlighted the presence of sinks directly adjacent to the ISO-5 area. A sink in the SCA (room -202A) was approximately three feet from the ISO-5 Compounding Aseptic area and one foot from a storage bin containing materials for the ISO-5 area, including sterile gloves and hand-drying wipes. This sink is regularly used for drug product preparation for Veterans.

Observation 3 stated that Beta-lactam drugs were produced without adequate containment, segregation, and/or cleaning to prevent cross-contamination. The firm lacked policies for de

## Related Documents

- [483 - 2020-02-27](https://www.keypedia.com/records/483/east-orange-va-medical-center/968f0756-24e4-4f51-bd46-ddfd1be2626a)

## Related Officers

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

Company: https://www.keypedia.com/companies/east-orange-va-medical-center/56a922e3-0f7f-4714-a2c1-37fb04ba2486

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248