American Red Cross Southeastern Michigan Region
Form 483 issued July 2, 2008 · Detroit, Michigan
- Inspection
- May 27 – Jul 2, 2008
- Investigator
- Cheryl A. Quinton
- Observations
- 7
- Pages
- 5
- FEI number
- 1873044
In short: On July 2, 2008, FDA issued a Form 483 with 7 observations to American Red Cross Southeastern Michigan Region in Detroit, Michigan (FEI 1873044) after an inspection that ran May 27 – Jul 2, 2008. The investigator was Cheryl A. Quinton. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
5 of 7 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100 (3×) · 606.20 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Problem resu~dlor delayed QA review. states- - CAP development is to be COIDJ)Jteu:a of CAP submission…
- 02
addresses the performance of ECs as a measure frequency of ECs, including sustained corrective actions, and…
- 03
According to the information must be gathered to present to the :y, · " : .~···…
- 04
Random platelet pools with positive bottle alarms are not always managed within a timely manner and…
This inspection in context
Cheryl A. Quinton
1 document · 2008
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 7 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?
Cheryl A. Quinton is named on this Form 483, for the inspection of May 27 – Jul 2, 2008. Each investigator has a profile showing what they cite most.
When was American Red Cross Southeastern Michigan Region inspected by FDA?
The inspection ran May 27 – Jul 2, 2008, and the Form 483 is dated July 2, 2008.
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.