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Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, Inc. FDA Record

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

Latest inspection NAI · Feb 1, 2012
No warning letters matched by name

Inspections 2

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, Inc. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, Inc." is on file.

What these totals cover: FDA records filed under the name "Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, Inc." and its spelling variant "Johnson And Johnson Healthcare Products Div. Mcneil-Ppc". Records filed under related names are not included; see Related names.

Latest recall: Z-0284-2027 · Sep 23, 2026 · filed under Ethicon
Latest inspection: Feb 1, 2012 · NAI

Newer recall under related name Ethicon: Sep 23, 2026, Z-0284-2027.

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	2	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, Inc. above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Ethicon	Same company group	78	208	15	0	Sep 23, 2026 (Z-0284-2027)
Johnson And Johnson Surgical Vision	Same company group	18	4	9	0	Jul 31, 2026 (Z-3064-2026)
Synthes (Usa) Products	Same company group	164	45	7	0	Feb 25, 2026 (Z-1703-2026)
Cerenovus	Same company group	1	10	11	0	Oct 2, 2025 (Z-0434-2026)
Ethicon Endo-Surgery Combines 2 spellings Ethicon Endo-Surgery: 54 recalls, 184 510(k)s, 8 inspections Ethicon Endo Surgery: 4 recalls, 2 510(k)s, 2 inspections	Same company group	58	186	10	0	Sep 11, 2025 (Z-0147-2026)
Johnson And Johnson Vision Care	Same company group	10	12	4	0	Jun 12, 2025 (Z-2163-2025)
Biosense Webster	Same company group	33	76	7	0	Jan 5, 2025 (Z-1205-2025)
Ethicon Sarl, A Johnson And Johnson	Same company group	2	0	2	0	Jun 11, 2024 (Z-2407-2024)
Depuy Orthopaedics	Same company group	155	210	11	2	Mar 12, 2024 (Z-1456-2024)
Depuy Spine	Same company group	36	71	9	0	May 20, 2022 (Z-1324-2022)
Janssen Pharmaceuticals	Same company group	4	0	32	2	Oct 23, 2018 (D-0218-2019)
Johnson And Johnson	Same company group	4	14	0	0	Dec 7, 2017 (D-0245-2018)

Recent FDA inspections

2 inspections from Sep 9, 2009 to Feb 1, 2012.

Date	Site	Product	Classification	FEI
Feb 1, 2012	Morris Plains, NJ	Devices	No Action Indicated (NAI)	2246407
Sep 9, 2009	Morris Plains, NJ	Devices	No Action Indicated (NAI)	2246407

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 2246407	Morris Plains, NJ	2	Feb 1, 2012

Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, Inc. and the FDA: common questions

Has Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, 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 Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, Inc.?

The most recent FDA inspection on file ended Feb 1, 2012 at Morris Plains, NJ and was classified NAI. FDA has 2 inspections of Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, Inc. on file.

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