FDA Inspection
Northeast Resins & Silicones, LLCNortheast Resins & Silicones, LLC – FDA Inspection, Jun 18, 2013
Record Details
This FDA Inspection record concerns Northeast Resins & Silicones, LLC, with an inspection on June 18, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 18, 2013
- Product Type
- Devices
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ID · 86a7f139-1b2a-47fb-99aa-aae8c0204309
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 837694
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Northeast Resins & Silicones, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 16, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 13, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 10, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Northeast Resins & Silicones, LLC
- FDA Inspection 1279023 - 2025-08-19
- FDA Inspection 1177800 - 2022-08-16
- FDA Inspection 994032 - 2016-12-13
- FDA Inspection 611540 - 2009-09-10
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