FDA Inspection 611540 — Northeast Resins & Silicones, LLC
The FDA completed an inspection of Northeast Resins & Silicones, LLC on Sep 10, 2009 in Southington, 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 10, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Southington, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3418 | 21 CFR 820.70(a)(3) | Standards or codes |
| 4189 | 21 CFR 820.198(a) | General |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |