FDA Inspection 785080 — Tarrant Eye Resources, Inc.
The FDA completed an inspection of Tarrant Eye Resources, Inc. on Jun 6, 2012 in Fort Worth, TX. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 6, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |