FDA Inspection 1014305 — Michael D. Williams, D.D.S., P.A.
The FDA completed an inspection of Michael D. Williams, D.D.S., P.A. on June 15, 2017 in Davie, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 15, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Davie, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |