American National Red Cross
FDA document issued March 28, 2005 · Irvine, California
- Inspection
- Jul 19 – Dec 13, 2004
- Observations
- 3
- Pages
- 8
In short: On March 28, 2005, FDA issued a FDA document with 3 observations to American National Red Cross in Irvine, California after an inspection that ran Jul 19 – Dec 13, 2004. Most observations concern biologics CGMP and production; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
2 of 3 observations on this document concern biologics cgmp.
What the letter cites
Preview: the opening words of each observation- 01
Failure to follow written production and process control procedure, as required by 21 CFR 211.100(b) and…
- 02
Failure to make and record a thorough investigation, including conclusions and follow-up, of any unexplained discrepancy…
- 03
Failure to maintain written standard operating procedures that include all steps to be followed in the…
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This inspection in context
Questions about this document
When was American National Red Cross inspected by FDA?
The inspection ran Jul 19 – Dec 13, 2004, and the FDA document is dated March 28, 2005.