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Mcneil Healthcare, Inc. FDA Record

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

Mcneil Healthcare, Inc. has 0 FDA recalls, 10 inspections, 19 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Mcneil Healthcare, Inc." is on file. FDA has published 5 Form 483s for Mcneil Healthcare, Inc..

What these totals cover: FDA records filed under the name "Mcneil Healthcare, Inc." and its spelling variant "Mcneil Healthcare".

Latest inspection: Sep 20, 2023 · VAI
Latest 510(k): Feb 3, 1994

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	19	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	10	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

Mcneil Healthcare, 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	0	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	0	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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Mcneil Healthcare, Inc. Form 483s

5 Form 483s published by FDA.

Date	Document	FEI
May 15, 2017	483	2650141
Jul 24, 2015	483	2650141
Jul 24, 2015	483	2650141
Jul 24, 2015	483	2650141
Jul 24, 2015	483	2650141

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

10 inspections from Dec 16, 2009 to Sep 20, 2023.

Date	Site	Product	Classification	FEI
Sep 20, 2023	Las Piedras, PR	Drugs	Voluntary Action Indicated (VAI)	2650141
Mar 31, 2021	Las Piedras, PR	Drugs	Voluntary Action Indicated (VAI)	2650141
Jun 21, 2018	Las Piedras, PR	Drugs	No Action Indicated (NAI)	2650141
Mar 31, 2015	Las Piedras, PR	Drugs	No Action Indicated (NAI)	2650141
Aug 27, 2013	Las Piedras, PR	Drugs	No Action Indicated (NAI)	2650141
Oct 26, 2011	Las Piedras, PR	Drugs	Voluntary Action Indicated (VAI)	2650141
Nov 2, 2010	Las Piedras, PR	Drugs	Official Action Indicated (OAI)	2650141
Feb 3, 2010	Las Piedras, PR	Drugs	Voluntary Action Indicated (VAI)	2650141
Jan 8, 2010	Las Piedras, PR	Drugs	Official Action Indicated (OAI)	2650141
Dec 16, 2009	San Juan, PR	Drugs	Voluntary Action Indicated (VAI)	3008094068

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 2650141	Las Piedras, PR	9	Sep 20, 2023
FEI 3008094068	San Juan, PR	1	Dec 16, 2009

Recent 510(k) clearances

19 510(k) clearances from Jan 13, 1994 to Feb 3, 1994.

K-Number	Device	Date
K935930	NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING	Feb 3, 1994
K935883	NEUROLOGICAL SPONGES	Feb 3, 1994
K935993	SURGICAL SPONGE X-RAY DETECTABLE	Feb 2, 1994
K935911	PACKING SPONGE	Jan 31, 1994
K935934	NON ADHERANT BURN PADS	Jan 31, 1994
K935882	TONSIL SPONGES	Jan 31, 1994
K935881	SPECIALTY SPONGES	Jan 31, 1994
K935910	X-RAY PACKING SPONGE	Jan 31, 1994
K935933	CUSTOM BURN DRESSING	Jan 14, 1994
K935938	BANDAGE ROLLS, STRETCH GAUZE ROLLS, TEXTURED GAUZE ROLLS	Jan 14, 1994
K935936	CONFORMING ROLL	Jan 14, 1994
K935937	POST OP SPONGE	Jan 14, 1994
K935939	GAUZE FLUFF	Jan 14, 1994
K935932	BURN COMPRESS	Jan 14, 1994
K935931	NON-WOVEN SPONGE	Jan 14, 1994
K935940	GAUZE SPONGE; DRAIN SPONGE	Jan 14, 1994
K935935	BURN GAUZE PADS	Jan 14, 1994
K935941	READY CUT GAUZE GAUZE BOLTS	Jan 14, 1994
K935942	SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE	Jan 13, 1994

Mcneil Healthcare, Inc. and the FDA: common questions

Has Mcneil Healthcare, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Mcneil Healthcare, 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 Mcneil Healthcare, Inc. received an FDA Form 483?

FDA has published 5 Form 483s for Mcneil Healthcare, Inc. in its reading room, the most recent dated May 15, 2017. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Mcneil Healthcare, Inc.?

The most recent FDA inspection on file ended Sep 20, 2023 at Las Piedras, PR and was classified VAI. FDA has 10 inspections of Mcneil Healthcare, Inc. on file, 2 of them classified OAI (official action indicated).

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