FDA Inspection 567627 — Dynarex Corporation
The FDA completed an inspection of Dynarex Corporation on Feb 20, 2009 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 20, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Orangeburg, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3382 | 21 CFR 820.198(e)(8) | Reply to complainant |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |