FDA Inspection 812553 — Pentax of America Inc
The FDA completed an inspection of Pentax of America Inc on December 18, 2012 in Montvale, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 18, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Montvale, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |