Hunter Holmes McGuire Veterans Affairs Medical Center
Form 483 issued March 11, 2015 · Richmond, Virginia
- Inspection
- Mar 9 – Mar 11, 2015
- Investigators
- Michael A. Charles· Zachery L. Miller
- Observations
- 3
- Pages
- 2
- FEI number
- 3003432602
In short: On March 11, 2015, FDA issued a Form 483 with 3 observations to Hunter Holmes McGuire Veterans Affairs Medical Center in Richmond, Virginia (FEI 3003432602) after an inspection that ran Mar 9 – Mar 11, 2015. The investigators were Michael A. Charles and Zachery L. Miller. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Written records are not made of…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
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 211.113
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 3 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Hunter Holmes McGuire Veterans Affairs Medical Center?
Michael A. Charles and Zachery L. Miller are named on this Form 483, for the inspection of Mar 9 – Mar 11, 2015. 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 Mar 9 – Mar 11, 2015, and the Form 483 is dated March 11, 2015.
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.