FDA Inspection 1080781 — ImpactOrtho Inc Hawaii
The FDA completed an inspection of ImpactOrtho Inc Hawaii on Feb 28, 2019 in Honolulu, HI. 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
- Feb 28, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Honolulu, HI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |