FDA Inspection 940935 — Dental Implant Specialties
The FDA completed an inspection of Dental Implant Specialties on Sep 3, 2015 in Los Angeles, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 3, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12405 | 21 CFR 1271.250(a) | Controlling the labeling of HCT/Ps |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |