American National Red Cross
Form 483 issued September 13, 2010 · San Jose, California
- Inspection
- Sep 7 – Sep 13, 2010
- Investigator
- Laverne Puckett
- Observations
- 1
- Pages
- 1
- FEI number
- 2972991
In short: On September 13, 2010, FDA issued a Form 483 with 1 observation to American National Red Cross in San Jose, California (FEI 2972991) after an inspection that ran Sep 7 – Sep 13, 2010. The investigator was Laverne Puckett. 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.
Most cited: 21 CFR 606.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to maintain storage…
This inspection in context
Laverne Puckett
1 document · 2010
Cites 606.160(b) (records) more than any other section. Most of their documents are for sites in California.
The firmAmerican National Red Cross history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American National Red Cross?
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?
Laverne Puckett is named on this Form 483, for the inspection of Sep 7 – Sep 13, 2010. Each investigator has a profile showing what they cite most.
When was American National Red Cross inspected by FDA?
The inspection ran Sep 7 – Sep 13, 2010, and the Form 483 is dated September 13, 2010.
How do I get the full Form 483 for American National Red Cross?
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.