American National Red Cross
FDA document issued November 21, 2006 · West Henrietta, New York
- Inspection
- Aug 24 – Dec 16, 2005
- Observations
- 11
- Pages
- 25
In short: On November 21, 2006, FDA issued a FDA document with 11 observations to American National Red Cross in West Henrietta, New York after an inspection that ran Aug 24 – Dec 16, 2005. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.160 (records).
At a glance
Observations span 1 system, led by biologics cgmp.
Most cited: 21 CFR 606.160 (2×)
What the letter cites
Preview: the opening words of each observation- 01
Within 20 days of receipt of this letter, provide to FDA the qualitative assessment protocol and…
- 02
Within 60 days of receipt of this letter, provide problem reports and problem files opened in…
- 03
Within 20 days of receipt of this letter, state when, since October 1,2004, regional and BHQ…
- 04
Within 60 days of receipt of this letter, increase the frequency of internal regional audits and…
This record's details are shown as context for the site. The file isn't for sale.
This inspection in context
Questions about this document
When was American National Red Cross inspected by FDA?
The inspection ran Aug 24 – Dec 16, 2005, and the FDA document is dated November 21, 2006.