FDA Inspection 1005494 — Dynarex Corporation
The FDA completed an inspection of Dynarex Corporation on Mar 2, 2017 in Orangeburg, NY. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 2, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Orangeburg, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |