FDA Inspection 1269739 — Best Dental Kit LLC
The FDA completed an inspection of Best Dental Kit LLC on May 1, 2025 in Shavertown, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 1, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Shavertown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |