American National Red Cross, Penn Jersey Region
Form 483 issued October 29, 2010 · Philadelphia, Pennsylvania
- Inspection
- Sep 2 – Oct 29, 2010
- Investigators
- Linda J. Mutchler· Nancy L. Kase
- Observations
- 17
- Pages
- 15
- FEI number
- 2573021
In short: On October 29, 2010, FDA issued a Form 483 with 17 observations to American National Red Cross, Penn Jersey Region in Philadelphia, Pennsylvania (FEI 2573021) after an inspection that ran Sep 2 – Oct 29, 2010. The investigators were Linda J. Mutchler and Nancy L. Kase. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
Observations span 1 system, led by biologics cgmp.
Most cited: 21 CFR 606.100 (8×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Oversight of Donor Management Consolidation: ARC has consolidated the donor management activities that were previously performed…
- 02
Quality Assurance (QA) at the DCSC: ARC has failed to follow Paragraph IV.A.2.a. of the Decree…
- 03
BHQ Audits of the DCSC: Although multiple Board of Governors Committee meeting notes state that Quality…
- 04
ARC has identified trends related to DRIRs beginning in 6/09, but has failed to promptly and…
This inspection in context
Linda J. Mutchler
1 document · 2010
Cites 606.100 (standard operating procedures) 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 17 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?
Linda J. Mutchler and Nancy L. Kase are named on this Form 483, for the inspection of Sep 2 – Oct 29, 2010. 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 Sep 2 – Oct 29, 2010, and the Form 483 is dated October 29, 2010.
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.