American Red Cross Southeastern Michigan Region
Form 483 issued September 27, 2010 · Detroit, Michigan
- Inspection
- Sep 27, 2010
- Investigators
- Barba Ra A. Rusin· Barbara A. Rusin· L'oreal D. Fowlkes
- Observations
- 3
- Pages
- 9
- FEI number
- 1873044
In short: On September 27, 2010, FDA issued a Form 483 with 3 observations to American Red Cross Southeastern Michigan Region in Detroit, Michigan (FEI 1873044) after an inspection that ran Sep 27, 2010. The investigators were Barba Ra A. Rusin, Barbara A. Rusin, L'oreal D. Fowlkes and Sherri J. Blessman. 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×) · 606.20 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written standard operating procedures including all steps to be followed in the collection, processing, storage, and…
- 02
E<lucation and training ofpersonnel as documented in the Learner Management System…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Barba Ra A. Rusin
1 document · 2010
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in Michigan.
The firmAmerican Red Cross Southeastern Michigan Region history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Southeastern Michigan Region?
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 Southeastern Michigan Region?
Barba Ra A. Rusin, Barbara A. Rusin, L'oreal D. Fowlkes and Sherri J. Blessman are named on this Form 483, for the inspection of Sep 27, 2010. Each investigator has a profile showing what they cite most.
When was American Red Cross Southeastern Michigan Region inspected by FDA?
The inspection ran Sep 27, 2010, and the Form 483 is dated September 27, 2010.
How do I get the full Form 483 for American Red Cross Southeastern Michigan Region?
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.