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Sanford Broadway Clinic Laboratory FDA Record

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

Latest inspection NAI · May 1, 2025
No warning letters matched by name

Inspections 6

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Sanford Broadway Clinic Laboratory has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sanford Broadway Clinic Laboratory" is on file.

What these totals cover: FDA records filed under the name "Sanford Broadway Clinic Laboratory".

Latest inspection: May 1, 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	6	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

Sanford Broadway Clinic Laboratory's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Sanford Broadway Clinic Laboratory: FDA inspections per year

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	1	0	0	0	0
2018	0	0	0	0	0
2017	0	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

6 inspections from Feb 28, 2012 to May 1, 2025.

Date	Site	Product	Classification	FEI
May 1, 2025	Fargo, ND	Biologics	No Action Indicated (NAI)	3006986912
May 28, 2019	Fargo, ND	Biologics	No Action Indicated (NAI)	3006986912
Dec 13, 2016	Fargo, ND	Biologics	No Action Indicated (NAI)	3006986912
Nov 19, 2014	Fargo, ND	Biologics	No Action Indicated (NAI)	3006986912
Apr 11, 2013	Fargo, ND	Biologics	Voluntary Action Indicated (VAI)	3006986912
Feb 28, 2012	Fargo, ND	Biologics	No Action Indicated (NAI)	3006986912

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 3006986912	Fargo, ND	6	May 1, 2025

Sanford Broadway Clinic Laboratory and the FDA: common questions

Has Sanford Broadway Clinic Laboratory received an FDA warning letter?

No FDA warning letter addressed to the name "Sanford Broadway Clinic Laboratory" 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 Sanford Broadway Clinic Laboratory received an FDA Form 483?

FDA has not published a Form 483 for "Sanford Broadway Clinic Laboratory" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Sanford Broadway Clinic Laboratory?

The most recent FDA inspection on file ended May 1, 2025 at Fargo, ND and was classified NAI. FDA has 6 inspections of Sanford Broadway Clinic Laboratory on file.

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