American Red Cross Biomedical Sevices Headquarters
Form 483 issued July 3, 2008 · Washington, District of Columbia
- Inspection
- Feb 5 – Jul 3, 2008
- Investigator
- Barbara A. Gullick
- Observations
- 3
- Pages
- 3
- FEI number
- 1122335
In short: On July 3, 2008, FDA issued a Form 483 with 3 observations to American Red Cross Biomedical Sevices Headquarters in Washington, District of Columbia (FEI 1122335) after an inspection that ran Feb 5 – Jul 3, 2008. The investigator was Barbara A. Gullick. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
2 of 3 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100 (1×) · 606.171 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
The American Red C;oss Biomedical Services failed to submit 48 hour co~;~signec notifications as : ~'…
This inspection in context
Barbara A. Gullick
1 document · 2008
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in District of Columbia.
The firmAmerican Red Cross Biomedical Sevices Headquarters history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Red Cross Biomedical Sevices Headquarters?
FDA listed 3 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.100 (standard operating procedures). The opening words of each observation are shown on this page.
Who inspected American Red Cross Biomedical Sevices Headquarters?
Barbara A. Gullick is named on this Form 483, for the inspection of Feb 5 – Jul 3, 2008. Each investigator has a profile showing what they cite most.
When was American Red Cross Biomedical Sevices Headquarters inspected by FDA?
The inspection ran Feb 5 – Jul 3, 2008, and the Form 483 is dated July 3, 2008.
How do I get the full Form 483 for American Red Cross Biomedical Sevices Headquarters?
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.