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The Sperm And Embryo Bank Of New Jersey, Inc. FDA Record

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

Latest inspection NAI · Mar 26, 2025
No warning letters matched by name

Inspections 8

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

The Sperm And Embryo Bank Of New Jersey, Inc. has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "The Sperm And Embryo Bank Of New Jersey, Inc." is on file.

What these totals cover: FDA records filed under the name "The Sperm And Embryo Bank Of New Jersey, Inc." and its spelling variant "Sperm And Embryo Bank Of New Jersey".

Latest inspection: Mar 26, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	8	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

The Sperm And Embryo Bank Of New Jersey, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

The Sperm And Embryo Bank Of New Jersey, Inc.: 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	1	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	1	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

8 inspections from Feb 18, 2010 to Mar 26, 2025.

Date	Site	Product	Classification	FEI
Mar 26, 2025	Mountainside, NJ	Biologics	No Action Indicated (NAI)	3003945123
Sep 5, 2023	Mountainside, NJ	Biologics	Voluntary Action Indicated (VAI)	3003945123
Nov 12, 2019	Mountainside, NJ	Biologics	No Action Indicated (NAI)	3003945123
Jul 10, 2018	Mountainside, NJ	Biologics	No Action Indicated (NAI)	3003945123
Aug 19, 2016	Mountainside, NJ	Biologics	No Action Indicated (NAI)	3003945123
Nov 14, 2013	Mountainside, NJ	Biologics	No Action Indicated (NAI)	3003945123
Apr 23, 2012	Mountainside, NJ	Biologics	No Action Indicated (NAI)	3003945123
Feb 18, 2010	Mountainside, NJ	Biologics	No Action Indicated (NAI)	3003945123

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 3003945123	Mountainside, NJ	8	Mar 26, 2025

The Sperm And Embryo Bank Of New Jersey, Inc. and the FDA: common questions

Has The Sperm And Embryo Bank Of New Jersey, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "The Sperm And Embryo Bank Of New Jersey, 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 The Sperm And Embryo Bank Of New Jersey, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "The Sperm And Embryo Bank Of New Jersey, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect The Sperm And Embryo Bank Of New Jersey, Inc.?

The most recent FDA inspection on file ended Mar 26, 2025 at Mountainside, NJ and was classified NAI. FDA has 8 inspections of The Sperm And Embryo Bank Of New Jersey, Inc. on file.

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