American Red Cross Blood Services
Form 483 issued September 23, 2010 · Cleveland, Ohio
- Inspection
- Jun 27 – Sep 23, 2010
- Investigator
- Nancy L. Neiger
- Observations
- 5
- Pages
- 3
- FEI number
- 1573019
In short: On September 23, 2010, FDA issued a Form 483 with 5 observations to American Red Cross Blood Services in Cleveland, Ohio (FEI 1573019) after an inspection that ran Jun 27 – Sep 23, 2010. The investigator was Nancy L. Neiger. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
4 of 5 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Records aro not CO'I)CWl'ently maintained with tho peromnance of each .~;ignlflcant step in the storage of…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Failure to follow Form Instruction: Donor Reaction and Injury Record procedure 15.4.form.015 and Work Instruction: Documenting…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Nancy L. Neiger
3 documents · 2010–2023
Cites 211.42(c)(10)(iv) (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmAmerican Red Cross Blood Services history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.100
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. The most-cited regulation is 21 CFR 606.100 (standard operating procedures). The opening words of each observation are shown on this page.
Who inspected American Red Cross Blood Services?
Nancy L. Neiger is named on this Form 483, for the inspection of Jun 27 – Sep 23, 2010. Each investigator has a profile showing what they cite most.
When was American Red Cross Blood Services inspected by FDA?
The inspection ran Jun 27 – Sep 23, 2010, and the Form 483 is dated September 23, 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.