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 · 2ca05404-b18a-4d40-ae92-d70e2d5ab708
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1106338
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.120(c)Storage
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(d)Implementing Personnel Procedures, Health, Cleanliness.
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Other FDA inspections of Conformis Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2026 | NAI | New England District Office | Postmarket Assurance: Medical Devices |
| July 8, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 14, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Conformis Inc.
- FDA Inspection 1282920 - 2026-01-13
- FDA Inspection 1146684 - 2021-07-08
- FDA Inspection 942038 - 2015-09-14
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