FDA Inspection 810445 — J. Pohler Inc.
The FDA completed an inspection of J. Pohler Inc. on Dec 13, 2012 in Davie, FL. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 13, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Davie, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |