American National Red Cross SW Region

Form 483 issued July 10, 2015 · Tulsa, Oklahoma

Inspection
Jul 28 – Aug 5, 2020
Investigator
Janice M. Hickok
Observations
1
Pages
1
FEI number
1673040

In short: On July 10, 2015, FDA issued a Form 483 with 1 observation to American National Red Cross SW Region in Tulsa, Oklahoma (FEI 1673040) after an inspection that ran Jul 28 – Aug 5, 2020. The investigator was Janice M. Hickok. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.160 (records).

At a glance

1 of 1 observations on this 483 concern biologics cgmp.

Biologics CGMP1

Most cited: 21 CFR 606.160 (1×)

What FDA observed

Preview: the opening words of each observation

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

  1. 01

    Recall records for distributed…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at American National Red Cross SW Region?

FDA listed 1 observation on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.160 (records). The opening words of each observation are shown on this page.

Who inspected American National Red Cross SW Region?

Janice M. Hickok is named on this Form 483, for the inspection of Jul 28 – Aug 5, 2020. Each investigator has a profile showing what they cite most.

When was American National Red Cross SW Region inspected by FDA?

The inspection ran Jul 28 – Aug 5, 2020, and the Form 483 is dated July 10, 2015.

How do I get the full Form 483 for American National Red Cross SW Region?

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.

$99Get it free