FDA Inspection 1013055 — The Metz Dental Laboratory Inc.
The FDA completed an inspection of The Metz Dental Laboratory Inc. on May 22, 2017 in Gahanna, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 22, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Gahanna, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |