FDA Inspection 848041 — American National Red Cross (The)
The FDA completed an inspection of American National Red Cross (The) on Sep 13, 2013 in West Henrietta, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 13, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- West Henrietta, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 35 | 21 CFR 606.40 | Clean & orderly |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |