Company
United StatesFoundation Medicine, Inc., Cambridge, MA – FDA Inspections
Inspection records and compliance data for Foundation Medicine, Inc. in Cambridge, Massachusetts. 6 FDA inspections on record (1 OAI), 1 Form 483, last inspected January 28, 2025.
Company Profile
This profile covers Foundation Medicine, Inc. based in Cambridge, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected August 22, 2016. Last inspected January 28, 2025.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design validation - user needs and intended uses1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 28, 2025 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1259315 |
| July 14, 2022 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1177142 |
| July 17, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1062851 |
| February 28, 2018 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1042552 |
| September 23, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 987340 |
| August 22, 2016 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 982822 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Foundation Medicine, Inc.
FEI Number
3010679023
Address
150 2nd St, Cambridge, Massachusetts 02141, United States
Country
United States
ID: 23e997e4-2aef-4b32-8491-5fe33a0f50b2