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OrthoSport Surgical, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

OrthoSport Surgical, Inc. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "OrthoSport Surgical, Inc." is on file.

What these totals cover: FDA records filed under the name "OrthoSport Surgical, Inc." and its spelling variant "Orthosport Surgical".

Latest inspection: Apr 18, 2025 · NAI

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	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

OrthoSport Surgical, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

4 inspections from Jan 3, 2012 to Apr 18, 2025.

Date	Site	Product	Classification	FEI
Apr 18, 2025	Roseville, CA	Biologics	No Action Indicated (NAI)	3008791882
Jul 11, 2017	Roseville, CA	Biologics	No Action Indicated (NAI)	3008791882
Aug 8, 2014	Roseville, CA	Biologics	No Action Indicated (NAI)	3008791882
Jan 3, 2012	Roseville, CA	Biologics	No Action Indicated (NAI)	3008791882

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: 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 3008791882	Roseville, CA	4	Apr 18, 2025

OrthoSport Surgical, Inc. and the FDA: common questions

Has OrthoSport Surgical, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "OrthoSport Surgical, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has OrthoSport Surgical, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "OrthoSport Surgical, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect OrthoSport Surgical, Inc.?

The most recent FDA inspection on file ended Apr 18, 2025 at Roseville, CA and was classified NAI. FDA has 4 inspections of OrthoSport Surgical, Inc. on file.

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