FDA Intel

American National Red Cross

FDA document issued September 13, 2013 · Tulsa, Oklahoma

Inspection
Feb 4 – Mar 1, 2013
Observations
2
Pages
6

In short: On September 13, 2013, FDA issued a FDA document with 2 observations to American National Red Cross in Tulsa, Oklahoma after an inspection that ran Feb 4 – Mar 1, 2013. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.160 (records).

At a glance

2 of 2 observations on this document concern biologics cgmp.

Biologics CGMP2

What the letter cites

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 606.160(e)21 CFR 606.160(b)(1)(vii)

    Failure to have records available from which unsuitable donors may be identified so that products from…

  2. 02
    21 CFR 606.100

    Failure to comply with Decree paragraph IV.A which requires ARC to "take steps necessary to ensure…

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This inspection in context

The firm

American National Red Cross history

All 16 documents on file for this site, in date order, with what was cited at each inspection.

Similar documents

Other sites cited under 606.160(e)

See how FDA wrote the same problem up elsewhere.

Questions about this document

When was American National Red Cross inspected by FDA?

The inspection ran Feb 4 – Mar 1, 2013, and the FDA document is dated September 13, 2013.