FDA Inspection 1003901 — PC Marketing, Inc.
The FDA completed an inspection of PC Marketing, Inc. on January 19, 2017 in Ridgefield, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 19, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ridgefield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3383 | 21 CFR 820.198(g) | Foreign complaint files |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 4437 | 21 CFR 803.40(b) | Report of malfunction likely to cause death or injury |
| 5236 | 21 CFR 1040.20(e)(1)(i) | Reproduction of labels |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |