U.S. Army Medical Research Institute of
Form 483 issued January 21, 2015 · Fort Detrick, Maryland
- Inspection
- Jan 12 – Jan 21, 2015
- Investigators
- Abhijit Raha· Cynthia A. Harris· Zhou Chen
- Observations
- 1
- Pages
- 2
- FEI number
- 1119919
In short: On January 21, 2015, FDA issued a Form 483 with 1 observation to U.S. Army Medical Research Institute of in Fort Detrick, Maryland (FEI 1119919) after an inspection that ran Jan 12 – Jan 21, 2015. The investigators were Abhijit Raha, Cynthia A. Harris and Zhou Chen. Most observations concern gLP; the most-cited regulation is 21 CFR 58.33 (study director).
At a glance
1 of 1 observations on this 483 concern glp.
Most cited: 21 CFR 58.33 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The study director failed to assure that all experimental data, including observations of unanticipated responses of…
This inspection in context
Abhijit Raha
1 document · 2015
Cites 58.33 (study director) more than any other section. Most of their documents are for sites in Maryland.
The firmU.S. Army Medical Research Institute of history
The site's inspection history, in date order.
Similar 483sOther sites cited under 58.33
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at U.S. Army Medical Research Institute of?
FDA listed 1 observation on this Form 483, mostly about gLP. The most-cited regulation is 21 CFR 58.33 (study director). The opening words of each observation are shown on this page.
Who inspected U.S. Army Medical Research Institute of?
Abhijit Raha, Cynthia A. Harris and Zhou Chen are named on this Form 483, for the inspection of Jan 12 – Jan 21, 2015. Each investigator has a profile showing what they cite most.
When was U.S. Army Medical Research Institute of inspected by FDA?
The inspection ran Jan 12 – Jan 21, 2015, and the Form 483 is dated January 21, 2015.
How do I get the full Form 483 for U.S. Army Medical Research Institute of?
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.