FDA Inspection 1199594 — MEDIA PLUS, LLC
The FDA completed an inspection of MEDIA PLUS, LLC on March 10, 2023 in Englewood Cliffs, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 10, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Englewood Cliffs, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |