Company
United StatesFibralign Corporation, Union City, CA – FDA Inspections
Inspection records and compliance data for Fibralign Corporation in Union City, California. 2 FDA inspections on record, 1 Form 483, last inspected June 03, 2025.
Company Profile
This profile covers Fibralign Corporation based in Union City, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 8, 2018. Last inspected June 3, 2025.
Most cited issue areas
- Design validation - production units1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 3, 2025 | Not classified | Medical Devices & Rad Health | 1274000 |
| November 8, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1071279 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Fibralign Corporation
FEI Number
3013037653
Address
32930 Alvarado Niles Rd Ste 350, Union City, California 94587, United States
Country
United States
ID: aea695ec-64e0-43f0-89c0-d0ab85079b81