American Red Cross Blood Services
Form 483 issued April 25, 2008 · Louisville, Kentucky
- Inspection
- Apr 14 – Apr 25, 2008
- Observations
- 5
- Pages
- 4
- FEI number
- 1073003
In short: On April 25, 2008, FDA issued a Form 483 with 5 observations to American Red Cross Blood Services in Louisville, Kentucky (FEI 1073003) after an inspection that ran Apr 14 – Apr 25, 2008. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
5 of 5 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100 (4×) · 606.171 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm failed to promptly, thoroughly and adequately investigate l correct and take steps to prevent…
- 02
The firm failed to notify ~onsignee and/or FDA's Baltimore District Office within 48 hours after learning…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Failure to notify FDA's Baltimore District Office and/or CBER within 45 days after learning that a…
This inspection in context
Questions about this 483
What did FDA find at American Red Cross Blood Services?
FDA listed 5 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 Apr 14 – Apr 25, 2008, and the Form 483 is dated April 25, 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.