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Playtex Manufacturing Inc FDA Inspection Record

FEI 3000717960 · Inspections, Form 483s, warning letters and import refusals

Playtex Manufacturing Inc is an FDA-registered facility (FEI 3000717960) located in Sidney, OH, US. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 7, 2025: Voluntary Action Indicated (VAI)
Inspections on record
4 (4 VAI)
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

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
Apr 7, 2025Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Written procedures not established/followed (21 CFR 211.67(b))
Computer control of master formula records (21 CFR 211.68(b))
Investigations of discrepancies, failures (21 CFR 211.192)
and 2 more
Sep 13, 2019Voluntary Action Indicated (VAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Investigations of discrepancies, failures (21 CFR 211.192)
Complaint Handling Procedure (21 CFR 211.198(a))
Jan 6, 2014Voluntary Action Indicated (VAI)Training , Education , Experience overall (21 CFR 211.25(a))
Inadequate number of personnel (21 CFR 211.25(c))
Equipment Design, Size and Location (21 CFR 211.63)
Computer control of master formula records (21 CFR 211.68(b))
and 8 more
Feb 23, 2011Voluntary Action Indicated (VAI)No citations listed

FDA record score

8 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 14, 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.

4 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIApr 7, 20256 x 16
Inspection classified VAISep 13, 20196 x 0.251.5
Inspection classified VAIJan 6, 201410 years or older, so it adds no points0
Inspection classified VAIFeb 23, 201110 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 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 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 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Playtex Manufacturing, Inc.
Location
Sidney, OH (US)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; MANUFACTURE
Source
decrs

FDA data resources

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