FDA Inspection 961411 — Collagen Matrix, Inc.
The FDA completed an inspection of Collagen Matrix, Inc. on November 25, 2015 in Allendale, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 25, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Allendale, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |