FDA Inspection 1311798 — Hard Manufacturing Co., Inc.
The FDA completed an inspection of Hard Manufacturing Co., Inc. on April 7, 2026 in Buffalo, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 7, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Buffalo, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23130 | ISO 13485:2016 Clause 7.3.9 | Procedures to control design and development changes not documented |