FDA Inspection 983099 — Pearson Dental Supplies Inc
The FDA completed an inspection of Pearson Dental Supplies Inc on August 15, 2016 in Sylmar, CA. 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
- August 15, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Sylmar, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12338 | 21 CFR 1271.180(b) | Review and approval-responsible person |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |