FDA Inspection 568474 — Newmark, Inc.
The FDA completed an inspection of Newmark, Inc. on Mar 4, 2009 in Cheshire, CT. 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). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 4, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cheshire, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3149 | 21 CFR 820.180 | Availability |
| 3159 | 21 CFR 820.184 | DHR content |
| 3162 | 21 CFR 820.184(b) | Quantity manufactured |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |