FDA Inspection 853812 — Diagnostica Stago, Inc.
The FDA completed an inspection of Diagnostica Stago, Inc. on Nov 8, 2013 in Parsippany, 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
- Nov 8, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Parsippany, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |