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Fibralign Corporation

FDA Regulatory Profile

Fibralign Corporation has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Fibralign Corporation".

Latest inspection: Nov 8, 2018 · VAI
Latest 510(k): Jan 8, 2016

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	1	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

Recent FDA Inspections

1 inspection on Nov 8, 2018.

Date	Site	Product	Classification	FEI
Nov 8, 2018	Union City, CA	Devices	Voluntary Action Indicated (VAI)	3013037653

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-Inspected Facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3013037653	Union City, CA	1	Nov 8, 2018

Recent 510(k) Clearances

1 510(k) clearance on Jan 8, 2016.

K-Number	Device	Date
K151083	BioBridge Collagen Matrix	Jan 8, 2016

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