FDA Inspection 1032513 — Fen Dental Mfg, Inc.
The FDA completed an inspection of Fen Dental Mfg, Inc. on Dec 1, 2017 in Medley, FL. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 1, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Medley, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |