FDA Inspection
Thermo Fisher Scientific (Asheville) LLCThermo Fisher Scientific (Asheville) LLC – FDA Inspection, Sep 10, 2010
Record Details
This FDA Inspection record concerns Thermo Fisher Scientific (Asheville) LLC, with an inspection on September 10, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 10, 2010
- Product Type
- Devices
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ID · 668b24c7-1036-41f9-a0ca-9b28956a2d57
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680936
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 110.80Reasonable precautions
- 21 CFR 110.37(e)(5)Signs
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
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Other FDA inspections of Thermo Fisher Scientific (Asheville) LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2025 | NAI | Cincinnati District Office | Postmarket Assurance: Medical Devices |
| August 23, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Thermo Fisher Scientific (Asheville) LLC
- FDA Inspection 1271739 - 2025-08-26
- FDA Inspection 1179348 - 2022-08-23
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