American Red Cross Blood Services
Form 483 issued September 24, 2010 · Pomona, California
- Inspection
- Aug 9 – Sep 24, 2010
- Investigators
- Donna L. Haab· Sonya L. Karsik· Y. Hu
- Observations
- 22
- Pages
- 21
- FEI number
- 2072994
In short: On September 24, 2010, FDA issued a Form 483 with 22 observations to American Red Cross Blood Services in Pomona, California (FEI 2072994) after an inspection that ran Aug 9 – Sep 24, 2010. The investigators were Donna L. Haab, Sonya L. Karsik and Y. Hu. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.160 (records).
At a glance
19 of 22 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.160 (10×) · 606.100 (8×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Information on deferred donors from each ARC Region is sent monthly to the Donor Client Support…
- 02
When potential duplicate donor pairs are determined to be false matches on Utility Reports by recording…
- 03
The following possible duplicate donor pairs were determined to be false matches based solely on information…
- 04
The following possible duplicate donor pairs were determined to be false matches based solely on information…
This inspection in context
Donna L. Haab
1 document · 2010
Cites 606.160 (records) more than any other section. Most of their documents are for sites in California.
The firmAmerican Red Cross Blood Services history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Red Cross Blood Services?
FDA listed 22 observations 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 Red Cross Blood Services?
Donna L. Haab, Sonya L. Karsik and Y. Hu are named on this Form 483, for the inspection of Aug 9 – Sep 24, 2010. Each investigator has a profile showing what they cite most.
When was American Red Cross Blood Services inspected by FDA?
The inspection ran Aug 9 – Sep 24, 2010, and the Form 483 is dated September 24, 2010.
How do I get the full Form 483 for American Red Cross Blood Services?
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.