Form 483, Jun 3, 2025
Form 483 issued June 3, 2025 · Fort Belvoir, Virginia
- Inspection
- May 28 – Jun 3, 2025
- Investigator
- La' Tasha M. Gunter
- Observations
- 3
- Pages
- 5
In short: On June 3, 2025, FDA issued a Form 483 with 3 observations to an FDA-inspected site in Fort Belvoir, Virginia after an inspection that ran May 28 – Jun 3, 2025. The investigator was La' Tasha M. Gunter. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.60 (equipment).
At a glance
3 of 3 observations on this 483 concern biologics cgmp.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the storage and distribution of blood and blood components is not observed, standardized…
- 0221 CFR 606.151
Records including signature by the physician requesting the procedure are not maintained…
- 03
Written standard operating procedures including all steps to be followed in the processing, storage and distribution…
This inspection in context
La' Tasha M. Gunter
2 documents · 2011–2025
Cites 118.4 (salmonella enteritidis (se) prevention measures) more than any other section. Most of their documents are for sites in Virginia.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.60
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 3 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.60 (equipment). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
La' Tasha M. Gunter is named on this Form 483, for the inspection of May 28 – Jun 3, 2025. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran May 28 – Jun 3, 2025, and the Form 483 is dated June 3, 2025.
How do I get the full Form 483 for an FDA-inspected site?
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.