FDA Inspection 890806 — Tarrant Eye Resources, Inc.
The FDA completed an inspection of Tarrant Eye Resources, Inc. on Jul 30, 2014 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 30, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12315 | 21 CFR 1271.160(b)(2) | Sharing of information (general) |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |