FDA Inspection 1030603 — Gulf Coast Regional Blood Center
The FDA completed an inspection of Gulf Coast Regional Blood Center on Nov 3, 2017 in Houston, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 3, 2017
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 98 | 21 CFR 606.100(c) | Thorough investigations |