FDA Inspection 718354 — Pentax of America Inc
The FDA completed an inspection of Pentax of America Inc on March 17, 2011 in Montvale, NJ. 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
- March 17, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Montvale, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |