VA New Jersey Healthcare System
Form 483 issued April 29, 2025 · East Orange, New Jersey
- Inspection
- Apr 22 – Apr 29, 2025
- Investigator
- Logan T. Williams
- Observations
- 3
- Pages
- 3
- FEI number
- 3011110195
In short: On April 29, 2025, FDA issued a Form 483 with 3 observations to VA New Jersey Healthcare System in East Orange, New Jersey (FEI 3011110195) after an inspection that ran Apr 22 – Apr 29, 2025. The investigator was Logan T. Williams. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Production areas have difficult to clean or contain porous, particle generating, or visibly…
- 02
The sinks are present directly adjacent to…
- 03
Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmVA New Jersey Healthcare System history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at VA New Jersey Healthcare System?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected VA New Jersey Healthcare System?
Logan T. Williams is named on this Form 483, for the inspection of Apr 22 – Apr 29, 2025. Each investigator has a profile showing what they cite most.
When was VA New Jersey Healthcare System inspected by FDA?
The inspection ran Apr 22 – Apr 29, 2025, and the Form 483 is dated April 29, 2025.
How do I get the full Form 483 for VA New Jersey Healthcare System?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.