American Red Cross Blood Services
Form 483 issued June 15, 2010 · Farmington, Connecticut
- Inspection
- May 4 – Jun 15, 2010
- Investigators
- Alice C. Silva· Anthony N. Onianwa
- Observations
- 5
- Pages
- 5
- FEI number
- 1273014
In short: On June 15, 2010, FDA issued a Form 483 with 5 observations to American Red Cross Blood Services in Farmington, Connecticut (FEI 1273014) after an inspection that ran May 4 – Jun 15, 2010. The investigators were Alice C. Silva and Anthony N. Onianwa. Most observations concern biologics CGMP and quality system.
At a glance
Biologics CGMP and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Wi;itten.standatd (>perating proce<tures including all.steps to be followed in the collection of blood and blood components…
- 02
Written records are not always made of…
- 03
The personnel responsible for the collection of blood or blood components are not adequate in number…
- 04
Laboratory records do not include the initials or signature of a second person showing that-the original…
This inspection in context
Alice C. Silva
1 document · 2010
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Connecticut.
The firmAmerican Red Cross Blood Services history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 606.100(b)
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 5 observations on this Form 483, mostly about biologics CGMP, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected American Red Cross Blood Services?
Alice C. Silva and Anthony N. Onianwa are named on this Form 483, for the inspection of May 4 – Jun 15, 2010. Each investigator has a profile showing what they cite most.
When was American Red Cross Blood Services inspected by FDA?
The inspection ran May 4 – Jun 15, 2010, and the Form 483 is dated June 15, 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.