Hunter Holmes McGuire Veterans Affairs Medical Center
Form 483 issued October 25, 2016 · Richmond, Virginia
- Inspection
- Oct 17, 2016
- Investigator
- Djamila Harouaka
- Observations
- 2
- Pages
- 2
- FEI number
- 3003432602
In short: On October 25, 2016, FDA issued a Form 483 with 2 observations to Hunter Holmes McGuire Veterans Affairs Medical Center in Richmond, Virginia (FEI 3003432602) after an inspection that ran Oct 17, 2016. The investigator was Djamila Harouaka. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.46 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The system for monitoring and maintaining environmental conditions in the aseptic…
- 02
The system for cleaning and disinfecting the aseptic…
This inspection in context
Djamila Harouaka
15 documents · 2015–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmHunter Holmes McGuire Veterans Affairs Medical Center history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.46
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hunter Holmes McGuire Veterans Affairs Medical Center?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling). The opening words of each observation are shown on this page.
Who inspected Hunter Holmes McGuire Veterans Affairs Medical Center?
Djamila Harouaka is named on this Form 483, for the inspection of Oct 17, 2016. Each investigator has a profile showing what they cite most.
When was Hunter Holmes McGuire Veterans Affairs Medical Center inspected by FDA?
The inspection ran Oct 17, 2016, and the Form 483 is dated October 25, 2016.
How do I get the full Form 483 for Hunter Holmes McGuire Veterans Affairs Medical Center?
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.