Department of Defense - Army
Form 483 issued May 9, 2025
- Inspection
- May 5 – May 9, 2025
- Investigator
- Steven D. Banks
- Observations
- 2
- Pages
- 3
- FEI number
- 1077442
In short: On May 9, 2025, FDA issued a Form 483 with 2 observations to Department of Defense - Army (FEI 1077442) after an inspection that ran May 5 – May 9, 2025. The investigator was Steven D. Banks. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 640.4 (collection of the blood).
At a glance
2 of 2 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 640.4 (1×) · 606.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile…
- 02
Written standard operating procedures including all steps to be followed in the distribution of blood and…
This inspection in context
Steven D. Banks
1 document · 2025
Cites 606.100 (standard operating procedures) more than any other section.
The firmDepartment of Defense - Army history
The site's inspection history, in date order.
Similar 483sOther sites cited under 640.4
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Department of Defense - Army?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 640.4 (collection of the blood). The opening words of each observation are shown on this page.
Who inspected Department of Defense - Army?
Steven D. Banks is named on this Form 483, for the inspection of May 5 – May 9, 2025. Each investigator has a profile showing what they cite most.
When was Department of Defense - Army inspected by FDA?
The inspection ran May 5 – May 9, 2025, and the Form 483 is dated May 9, 2025.
How do I get the full Form 483 for Department of Defense - Army?
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.