FDA Inspection 1081673 — PC Marketing, Inc.
The FDA completed an inspection of PC Marketing, Inc. on Mar 7, 2019 in Ridgefield, NJ. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 7, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Ridgefield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 4437 | 21 CFR 803.40(b) | Report of malfunction likely to cause death or injury |