VA New Jersey Healthcare System
Form 483 issued February 27, 2020 · East Orange, New Jersey
- Inspection
- Feb 27, 2020
- Observations
- 7
- Pages
- 5
- FEI number
- 3011110195
In short: On February 27, 2020, FDA issued a Form 483 with 7 observations to VA New Jersey Healthcare System in East Orange, New Jersey (FEI 3011110195) after an inspection that ran Feb 27, 2020. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 7 of 7 observations.
Most cited: 21 CFR 211.113 (3×) · 211.67 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel touched equipment or other surface located outside the ISO 5 classified aseptic processing area with…
- 02
Your firm produced drugs while construction was underway in an adjacent area without adequate controls to…
- 03
Vermin was observed in an area immediately adjacent to…
- 04
The ISO classified aseptic processing areas are difficult to clean and contained visibly…
This inspection in context
Questions about this 483
What did FDA find at VA New Jersey Healthcare System?
FDA listed 7 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was VA New Jersey Healthcare System inspected by FDA?
The inspection ran Feb 27, 2020, and the Form 483 is dated February 27, 2020.
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.