FDA Inspection
Fibralign CorporationFibralign Corporation – FDA Inspection, Nov 8, 2018
Record Details
This FDA Inspection record concerns Fibralign Corporation, with an inspection on November 8, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 75e27e53-acd6-4d6a-aebb-54fa60b1dcaa
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1071279
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of Fibralign Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2025 | Not classified | San Francisco District Office |
Other documents for Fibralign Corporation
- FDA Inspection 1274000 - 2025-06-03
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