FDA Inspection
Conformis, Inc.Conformis, Inc. – FDA Inspection, Sep 7, 2018
Record Details
This FDA Inspection record concerns Conformis, Inc., with an inspection on September 7, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e8edafe7-8085-46b1-8f7e-b96260c6f0e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1064815
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Conformis, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 20, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 12, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 18, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Conformis, Inc.
- FDA Inspection 1199287 - 2023-03-09
- FDA Inspection 1102363 - 2019-09-20
- FDA Inspection 929855 - 2015-06-12
- FDA Inspection 823060 - 2013-03-18
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