FDA Inspection 926494 — HOYA Corporation PENTAX Miyagi Factory
The FDA completed an inspection of HOYA Corporation PENTAX Miyagi Factory on Apr 24, 2015 in Kurihara. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 24, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kurihara (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |