American Red Cross Blood Services
Form 483 issued July 28, 2008 · West Henrietta, New York
- Inspection
- Jul 28, 2008
- Investigators
- Karen T. Kaveny· Kirsten L. Lene
- Observations
- 7
- Pages
- 6
- FEI number
- 3002957282
In short: On July 28, 2008, FDA issued a Form 483 with 7 observations to American Red Cross Blood Services in West Henrietta, New York (FEI 3002957282) after an inspection that ran Jul 28, 2008. The investigators were Karen T. Kaveny and Kirsten L. Lene. 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 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm has failed to thoroughly and adequately investigate, develop root cause, correct and take steps…
- 02
Observation 2: scanned text, readable in the full document.
- 03
perform Effectiveness Checks, developed as part of the formal Problems and for their due date. Your…
- 04
within 5 days as required. Your written that the QA review CAP's and reject or approve…
This inspection in context
Karen T. Kaveny
1 document · 2008
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in New York.
The firmAmerican Red Cross Blood Services 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 Blood Services?
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 Blood Services?
Karen T. Kaveny and Kirsten L. Lene are named on this Form 483, for the inspection of Jul 28, 2008. Each investigator has a profile showing what they cite most.
When was American Red Cross Blood Services inspected by FDA?
The inspection ran Jul 28, 2008, and the Form 483 is dated July 28, 2008.
How do I get the full Form 483 for American Red Cross Blood Services?
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.