FDA Inspection
Foundation Medicine, Inc.Foundation Medicine, Inc. – FDA Inspection, Feb 28, 2018
Record Details
This FDA Inspection record concerns Foundation Medicine, Inc., with an inspection on February 28, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9fc05315-668f-4cbb-b03e-41375183d08f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042552
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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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 |
| 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 1259315 - 2025-01-28
- FDA Inspection 1177142 - 2022-07-14
- FDA Inspection 1062851 - 2018-07-17
- FDA Inspection 987340 - 2016-09-23
- FDA Inspection 982822 - 2016-08-22
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