American National Red Cross, National Testing Lab
Form 483 issued June 16, 2010 · Detroit, Michigan
- Inspection
- May 25 – Jun 16, 2010
- Investigators
- Barbara A. Rusin· L'oreal D. Fowlkes· Sherri J. Blessman
- Observations
- 2
- Pages
- 2
- FEI number
- 1000306317
In short: On June 16, 2010, FDA issued a Form 483 with 2 observations to American National Red Cross, National Testing Lab in Detroit, Michigan (FEI 1000306317) after an inspection that ran May 25 – Jun 16, 2010. The investigators were Barbara A. Rusin, L'oreal D. Fowlkes and Sherri J. Blessman. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.20 (personnel).
At a glance
Observations span 1 system, led by biologics cgmp.
Most cited: 21 CFR 606.20 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Annual competency reviews and/or quality assurance process reviews of operators did not effectively identify steps which…
- 02
Failure to adequately investigate…
This inspection in context
Barbara A. Rusin
2 documents · 2010
Cites 606.20 (personnel) more than any other section. Most of their documents are for sites in Michigan.
The firmAmerican National Red Cross, National Testing Lab history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.20
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American National Red Cross, National Testing Lab?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.20 (personnel). The opening words of each observation are shown on this page.
Who inspected American National Red Cross, National Testing Lab?
Barbara A. Rusin, L'oreal D. Fowlkes and Sherri J. Blessman are named on this Form 483, for the inspection of May 25 – Jun 16, 2010. Each investigator has a profile showing what they cite most.
When was American National Red Cross, National Testing Lab inspected by FDA?
The inspection ran May 25 – Jun 16, 2010, and the Form 483 is dated June 16, 2010.
How do I get the full Form 483 for American National Red Cross, National Testing Lab?
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.