FDA Inspection 868183 — Hard Manufacturing Co., Inc.
The FDA completed an inspection of Hard Manufacturing Co., Inc. on February 28, 2014 in Buffalo, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 28, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Buffalo, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |