Johnson & Johnson Consumer, Inc FDA Inspection Record

FEI 1000150647 · Inspections, Form 483s, warning letters and import refusals

Johnson & Johnson Consumer, Inc is an FDA-inspected facility (FEI 1000150647) located in Lancaster, PA, US. RegDataLab tracks 4 FDA inspections at this facility.

Reviewing Johnson & Johnson Consumer, Inc as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Johnson & Johnson Consumer, Inc yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

What FDA found at this site

Latest inspection
Mar 24, 2021: Voluntary Action Indicated (VAI)
Inspections on record
4 (1 OAI, 3 VAI)
Last OAI inspection
Jul 9, 2010
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents
1 in FDA's reading room
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
Mar 24, 2021Voluntary Action Indicated (VAI)Investigations of discrepancies, failures (21 CFR 211.192)
Mar 27, 2015Voluntary Action Indicated (VAI)Authority lacking to review records, investigate errors (21 CFR 211.22(a))
Control procedures to monitor and validate performance (21 CFR 211.110(a))
Aug 30, 2013Voluntary Action Indicated (VAI)Equipment Design, Size and Location (21 CFR 211.63)
Investigations of discrepancies, failures (21 CFR 211.192)
Jul 9, 2010Official Action Indicated (OAI)No citations listed

Form 483s and inspection documents

  • 483 on FDA.gov
    Issued Jul 9, 2010 (dates printed on the document). FDA listing date Jul 11, 2015. Published by FDA Jan 18, 2024.

Facility details

Company
Johnson & Johnson Consumer, Inc
Location
Lancaster, PA (US)
Source
inspections

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