FDA Inspection
Foundation Medicine, Inc.Foundation Medicine, Inc. – FDA Inspection, Jan 28, 2025
Record Details
This FDA Inspection record concerns Foundation Medicine, Inc., with an inspection on January 28, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a618b4a0-625a-40f1-988e-e936c78b8caa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1259315
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Foundation Medicine, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| August 22, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Foundation Medicine, Inc.
- FDA Inspection 1177142 - 2022-07-14
- FDA Inspection 1062851 - 2018-07-17
- FDA Inspection 1042552 - 2018-02-28
- FDA Inspection 987340 - 2016-09-23
- FDA Inspection 982822 - 2016-08-22
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