Key facts
| Firm | East Orange VA Medical Center |
|---|---|
| FEI / inspection ID | 3011110195 |
| Inspection end date | April 29, 2025 |
| Citation count | 3 |
Citations explained
Observation 1 — Production areas have difficult to clean or contain porous, pa1ti cle generating
Production areas have difficult to clean or contain porous, pa1ti cle generating, or visibly duty equipment or surfaces. Specifica lly, On 4/22/2025 I observed the following contamination in your fnm's Segregated Compounding Area (SCA) located in roorrfl -202A: • Rust was observed on the table legs of the work bench approximately 2 feet from the ISO-5 Sterile Compounding[(5) (~ l • Discoloration was observed on the HEPA pre-filter that is located directl~ beloy an an· return vent in the SCA. This pre-filter is a pa1t of the I SO -5 Sterile Compounding (5) (~ l. On 4/22/2025 I observed the following contamination adjacent to your fnm 's SCA located in roo nQ - 167: • Puddled li quid was observed in the bottom of a cabinet within the closet containing cleaners and a sink used fo r hand washing prior to production within the SCA. This closet is located dn·ectly adjacent to roo n(J -1 67 and the doo1way to.
Observation 2 — The sinks are present dn·ectly adjacent to the ISO 5 ar ea
The sinks are present dn·ectly adjacent to the ISO 5 ar ea. EMPLOY EE($) SIGNATURE DATE lSSUEO SEE REVERSE Lo gan T Williams, Investigat o r 4/29/2025 OF THIS PAGE ~ r200'29SSOSS X •-SZ"°-'04-29-2025
Observation 3 — Beta-lactam diugs were produced without providing adequate containment, segregation, and/or cleaning of
Beta-lactam diugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination. Specifica lly, Your fnm does not have policies in place to deactivate Penicillin and Beta Lactam products a ft er production. Your fnm has produced approximately 4 H IV bags of Penicillin G Potassium and l6ll.tl IV bags of Meropenem since Janua1y 1st, 2025, in yo ur fnm's main Segregated Compounding Area. In addition, your fnm has not demonstrated that deactivation of Beta Lactam and Penicillin products occur with the cleaning agen ts used. *DATES OF INSPECTION 4/22/2025(Tue), 4/23/2025(Wed), 4/24/2025(Thu), 4/25/2025(Fri), 4/28/2025(Mon), 4/29/2025(Tu e) SEE REVERSE OF THIS PAGE EMPLOYE E($) SIGNATURE Lo gan T Williams, Investigat o r DATE lSSUEO 4/29/2025
What a Form 483 means
A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.
East Orange VA Medical Center’s FDA history
Argus HQ has recorded 1 total FDA action tied to East Orange VA Medical Center: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Has East Orange VA Medical Center had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for East Orange VA Medical Center so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3011110195.
- Is a Form 483 the same as a Warning Letter?
- No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
- Where can I read the full Form 483?
- The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
See if this 483 escalates to a warning letter — before your auditor asks.
Free weekly briefing tracks every FDA inspection outcome.
Related enforcement actions
Full FDA history for East Orange VA Medical CenterCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2025). Form 483 Record: East Orange VA Medical Center, April 29, 2025 — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-east-orange-va-medical-center-2025-04-29-3011110195
"Form 483 Record: East Orange VA Medical Center, April 29, 2025 — 3 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-east-orange-va-medical-center-2025-04-29-3011110195.
Argus HQ Research. "Form 483 Record: East Orange VA Medical Center, April 29, 2025 — 3 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-east-orange-va-medical-center-2025-04-29-3011110195.
@misc{argushq_argushq_ai_483_fda_483_east_orange_va_medical_center_2025_04_29_3011110195_2025,
title = {Form 483 Record: East Orange VA Medical Center, April 29, 2025 — 3 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-east-orange-va-medical-center-2025-04-29-3011110195},
note = {Accessed: July 13, 2026}
}