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Delaware Institute For Reproductive Medicine, P.A FDA Record

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

Latest inspection NAI · Sep 16, 2025
No warning letters matched by name

Inspections 7

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Delaware Institute For Reproductive Medicine, P.A has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Delaware Institute For Reproductive Medicine, P.A" is on file.

What these totals cover: FDA records filed under the name "Delaware Institute For Reproductive Medicine, P.A".

Latest inspection: Sep 16, 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	7	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

Delaware Institute For Reproductive Medicine, P.A's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Delaware Institute For Reproductive Medicine, P.A: 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	1	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	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

7 inspections from Mar 31, 2011 to Sep 16, 2025.

Date	Site	Product	Classification	FEI
Sep 16, 2025	Newark, DE	Biologics	No Action Indicated (NAI)	3003939643
Oct 26, 2022	Newark, DE	Biologics	No Action Indicated (NAI)	3003939643
Jun 20, 2019	Newark, DE	Biologics	Voluntary Action Indicated (VAI)	3003939643
Jun 8, 2017	Newark, DE	Biologics	No Action Indicated (NAI)	3003939643
May 13, 2015	Newark, DE	Biologics	No Action Indicated (NAI)	3003939643
May 16, 2013	Newark, DE	Biologics	No Action Indicated (NAI)	3003939643
Mar 31, 2011	Newark, DE	Biologics	Voluntary Action Indicated (VAI)	3003939643

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 3003939643	Newark, DE	7	Sep 16, 2025

Delaware Institute For Reproductive Medicine, P.A and the FDA: common questions

Has Delaware Institute For Reproductive Medicine, P.A received an FDA warning letter?

No FDA warning letter addressed to the name "Delaware Institute For Reproductive Medicine, P.A" 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 Delaware Institute For Reproductive Medicine, P.A received an FDA Form 483?

FDA has not published a Form 483 for "Delaware Institute For Reproductive Medicine, P.A" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Delaware Institute For Reproductive Medicine, P.A?

The most recent FDA inspection on file ended Sep 16, 2025 at Newark, DE and was classified NAI. FDA has 7 inspections of Delaware Institute For Reproductive Medicine, P.A on file.

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