FDA Inspection 774189 — Orthority Corporation
The FDA completed an inspection of Orthority Corporation on Mar 27, 2012 in Caguas, PR. 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
- Mar 27, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Caguas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |