FDA Inspection 552972 — Dorado Health Inc
The FDA completed an inspection of Dorado Health Inc on December 5, 2008 in Manati, PR. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 5, 2008
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Manati, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |