FDA Inspection 953329 — Buffalo Dental Manufacturing Co., Inc.
The FDA completed an inspection of Buffalo Dental Manufacturing Co., Inc. on December 22, 2015 in Syosset, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 22, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Syosset, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3159 | 21 CFR 820.184 | DHR content |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 512 | 21 CFR 820.65 | Traceability Lack of or inadequate {see also 820.120(e)} |