FDA Inspection 925512 — Hoya Corporation - Pentax Life Division
The FDA completed an inspection of Hoya Corporation - Pentax Life Division on Apr 21, 2015 in Akishima. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 21, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Akishima (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |