American Red Cross Blood Services
Form 483 issued January 24, 2008 · Farmington, Connecticut
- Inspection
- Nov 12 – Nov 24, 2008
- Observations
- 3
- Pages
- 2
- FEI number
- 1273014
In short: On January 24, 2008, FDA issued a Form 483 with 3 observations to American Red Cross Blood Services in Farmington, Connecticut (FEI 1273014) after an inspection that ran Nov 12 – Nov 24, 2008. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
3 of 3 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100 (2×) · 606.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to adequately investigate, correct, and prevent recurring problem of distributing blood and blood components…
- 02
Written procedure was not followed regarding handling of…
- 03
Failure to sign and…
This inspection in context
Questions about this 483
What did FDA find at American Red Cross Blood Services?
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.
When was American Red Cross Blood Services inspected by FDA?
The inspection ran Nov 12 – Nov 24, 2008, and the Form 483 is dated January 24, 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.