FDA Inspection 684542 — AdDent, Inc.
The FDA completed an inspection of AdDent, Inc. on Oct 5, 2010 in Danbury, CT. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 5, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Danbury, CT (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 |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3239 | 21 CFR 820.72(b) | Remedial action - documentation |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |