FDA Inspection
Conformis, Inc.Conformis, Inc. – FDA Inspection, Sep 20, 2019
Record Details
This FDA Inspection record concerns Conformis, Inc., with an inspection on September 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c5f9d5ba-6057-4920-8de1-4214b9d89420
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102363
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(g)Design validation - Risk analysis
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 7, 2018 | 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 1064815 - 2018-09-07
- FDA Inspection 929855 - 2015-06-12
- FDA Inspection 823060 - 2013-03-18
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