FDA Inspection 584142 — Georgia Eye Bank, Inc.
The FDA completed an inspection of Georgia Eye Bank, Inc. on May 21, 2009 in Atlanta, GA. 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) (NAI)
- End Date
- May 21, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |