FDA Inspection
Foundation Medicine, Inc.Foundation Medicine, Inc. – FDA Inspection, Aug 22, 2016
Record Details
This FDA Inspection record concerns Foundation Medicine, Inc., with an inspection on August 22, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Foundation Medicine, Inc.
- Inspection Date
- August 22, 2016
- Product Type
- Devices
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ID · 4f3be8c8-6861-4176-a602-1b3f32bf9aa3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 982822
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.42Sponsor began study before IRB/FDA approval
- 21 CFR 820.30(g)Design validation - user needs and intended uses
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Foundation Medicine, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2025 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 14, 2022 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| July 17, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 28, 2018 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| September 23, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Foundation Medicine, Inc.
- FDA Inspection 1259315 - 2025-01-28
- FDA Inspection 1177142 - 2022-07-14
- FDA Inspection 1062851 - 2018-07-17
- FDA Inspection 1042552 - 2018-02-28
- FDA Inspection 987340 - 2016-09-23
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