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New York Reproductive Wellness Medicine, P.C. FDA Record

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

Latest inspection VAI · Mar 28, 2025
No warning letters matched by name

Inspections 9

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

New York Reproductive Wellness Medicine, P.C. has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "New York Reproductive Wellness Medicine, P.C." is on file.

What these totals cover: FDA records filed under the name "New York Reproductive Wellness Medicine, P.C." and its spelling variant "New York Reproductive Wellness Medicine, P.C".

Latest inspection: Mar 28, 2025 · VAI

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	9	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

New York Reproductive Wellness Medicine, P.C.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

New York Reproductive Wellness Medicine, P.C.: 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	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

9 inspections from Dec 10, 2013 to Mar 28, 2025.

Date	Site	Product	Classification	FEI
Mar 28, 2025	Syosset, NY	Biologics	Voluntary Action Indicated (VAI)	3010122933
Apr 7, 2023	Syosset, NY	Biologics	No Action Indicated (NAI)	3010122933
Nov 18, 2019	Syosset, NY	Biologics	No Action Indicated (NAI)	3010122933
Oct 5, 2018	Melville, NY	Biologics	No Action Indicated (NAI)	3010643755
Oct 10, 2017	Syosset, NY	Biologics	No Action Indicated (NAI)	3010122933
Oct 24, 2016	Melville, NY	Biologics	No Action Indicated (NAI)	3010643755
Dec 10, 2015	Syosset, NY	Biologics	Voluntary Action Indicated (VAI)	3010122933
Dec 10, 2014	Melville, NY	Biologics	No Action Indicated (NAI)	3010643755
Dec 10, 2013	Syosset, NY	Biologics	Voluntary Action Indicated (VAI)	3010122933

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

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3010122933	Syosset, NY	6	Mar 28, 2025
FEI 3010643755	Melville, NY	3	Oct 5, 2018

New York Reproductive Wellness Medicine, P.C. and the FDA: common questions

Has New York Reproductive Wellness Medicine, P.C. received an FDA warning letter?

No FDA warning letter addressed to the name "New York Reproductive Wellness Medicine, P.C." 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 New York Reproductive Wellness Medicine, P.C. received an FDA Form 483?

FDA has not published a Form 483 for "New York Reproductive Wellness Medicine, P.C." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect New York Reproductive Wellness Medicine, P.C.?

The most recent FDA inspection on file ended Mar 28, 2025 at Syosset, NY and was classified VAI. FDA has 9 inspections of New York Reproductive Wellness Medicine, P.C. on file.

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