American National Red Cross
FDA document issued January 13, 2012 · Washington, District of Columbia
- Inspection
- Apr 5 – Oct 29, 2010
- Observations
- 5
- Pages
- 32
In short: On January 13, 2012, FDA issued a FDA document with 5 observations to American National Red Cross in Washington, District of Columbia after an inspection that ran Apr 5 – Oct 29, 2010. 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 document concern biologics cgmp.
Most cited: 21 CFR 606.100 (3×) · 21 CFR 606.1 (2×)
What the letter cites
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 606.160(e)21 CFR 606.1
Decree paragraph IV.B.lO requires ARC to maintain a National Donor Deferral Register (NDDR) that contains an…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Failure to promptly, thoroughly, and adequately investigate and correct problems in accordance with the Decree and…
- 04
During the inspection of the DCSC, FDA observed that ARC identified trends 16 related to DRIRs…
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This inspection in context
Questions about this document
When was American National Red Cross inspected by FDA?
The inspection ran Apr 5 – Oct 29, 2010, and the FDA document is dated January 13, 2012.