FDA Inspection 770808 — Orthobone, Inc.
The FDA completed an inspection of Orthobone, Inc. on March 2, 2012 in San Juan, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 2, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Juan, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12334 | 21 CFR 1271.170(c) | Trained or re-trained as necessary |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |