FDA Inspection 776526 — Buffalo Dental Manufacturing Co., Inc.
The FDA completed an inspection of Buffalo Dental Manufacturing Co., Inc. on April 10, 2012 in Syosset, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 10, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Syosset, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 636 | 21 CFR 803.17(b)(2) | Reports and information documentation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |