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

FEI 2246407 · Inspections, Form 483s, warning letters and import refusals

Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, Inc. is an FDA-inspected facility (FEI 2246407) located in Morris Plains, NJ, US. RegDataLab tracks 2 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Feb 1, 2012: No Action Indicated (NAI)
Inspections on record
2 (2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
4, latest Apr 2, 2007
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Feb 1, 2012No Action Indicated (NAI)No citations listed
Sep 9, 2009No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Apr 2, 2007Class ID-823-2007Listerine Agent Cool Blue Plaque-Detecting Rinse, Glacier Mint Flavor, 250 mL and 500 mL… and 1 more product
Firm's testing confirmed microbial contamination in some bottles, including gram negative organisms
Oct 11, 2006Class IIIF-093-7Lubriderm Moisture Mitts, skin moisturizing lotion.
Lubriderm Moisture Mitts were tested and found to contain Aspergillus fumigatus, Aspergillus versicolor, and Penicillium sp.
Jan 30, 2006Class IIID-205-6Visine A Antihistamine and Redness Relief Eye Drops, Ophthalmic solution, Pheniramine…
Container Leakage: Promotional packager used knives to open boxes containing the plastic bottles of Visine-A in violation of SOP. Bottles…
Oct 1, 2003Class IIID-062-4Actifed Cold & Allergy tablets (60 mg Pseudoephedrine HCl , 2.5 mg Triprolidine HCl), 12…
Misbranding; some of the dosing information and/or ingredient listing information may be missing from the carton.

FDA record score

0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

1 record behind this number
RecordDatePoints x age weightAdds
Class I recall D-823-2007, this FEI as the recalling firmApr 2, 200710 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Johnson & Johnson Healthcare Products Div. Mcneil-Ppc, Inc.
Location
Morris Plains, NJ (US)
Source
inspections

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.