Company
United StatesConformis, Inc., Billerica, MA – FDA Inspections
Inspection records and compliance data for Conformis, Inc. in Billerica, Massachusetts. 5 FDA inspections on record, 3 Form 483s, last inspected March 09, 2023.
Company Profile
This profile covers Conformis, Inc. based in Billerica, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected March 18, 2013. Last inspected March 9, 2023.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 9, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1199287 |
| September 20, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1102363 |
| September 7, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1064815 |
| June 12, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 929855 |
| March 18, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 823060 |
FDA documents
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Company Information
Name
Conformis, Inc.
FEI Number
3009844603
Address
600 Technology Park Dr # 400, Billerica, Massachusetts 01821, United States
Country
United States
ID: 4d049221-15de-4b53-addf-68ea7fed8cbc