American National Red Cross, Penn Jersey Region
Form 483 issued July 29, 2008 · Philadelphia, Pennsylvania
- Inspection
- Jul 21 – Jul 29, 2008
- Investigators
- Ann Marie Karnick· Kimberly A. Dugas· Michele M. Falchek
- Observations
- 2
- Pages
- 3
- FEI number
- 2573021
In short: On July 29, 2008, FDA issued a Form 483 with 2 observations to American National Red Cross, Penn Jersey Region in Philadelphia, Pennsylvania (FEI 2573021) after an inspection that ran Jul 21 – Jul 29, 2008. The investigators were Ann Marie Karnick, Kimberly A. Dugas and Michele M. Falchek. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
2 of 2 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to perforro a thorough investigation and make a record of the conclusions and follow-up…
- 02
Written standard operating procedures including all steps to be followed in the collection and processing of…
This inspection in context
Ann Marie Karnick
2 documents · 2004–2008
Cites 1271.270 (records) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAmerican National Red Cross, Penn Jersey Region history
All 3 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 National Red Cross, Penn Jersey Region?
FDA listed 2 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 National Red Cross, Penn Jersey Region?
Ann Marie Karnick, Kimberly A. Dugas and Michele M. Falchek are named on this Form 483, for the inspection of Jul 21 – Jul 29, 2008. Each investigator has a profile showing what they cite most.
When was American National Red Cross, Penn Jersey Region inspected by FDA?
The inspection ran Jul 21 – Jul 29, 2008, and the Form 483 is dated July 29, 2008.
How do I get the full Form 483 for American National Red Cross, Penn Jersey 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.