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Playtex Manufacturing Inc FDA Inspection Record

FEI 1027735 · Inspections, Form 483s, warning letters and import refusals

Playtex Manufacturing Inc is an FDA-inspected facility (FEI 1027735) located in Ormond Beach, FL, US. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Jul 10, 2026: Official Action Indicated (OAI)
Inspections on record
5 (1 OAI, 3 VAI, 1 NAI)
Last OAI inspection
Jul 10, 2026
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
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
Jul 10, 2026Official Action Indicated (OAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Sanitation--buildings not clean, free of infestation (21 CFR 211.56(a))
Scientifically sound laboratory controls (21 CFR 211.160(b))
Written record of investigation incomplete (21 CFR 211.192)
Apr 19, 2023Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
input/output verification (21 CFR 211.68(b))
Written Procedures Not Followed (21 CFR 211.80(a))
Written record of investigation incomplete (21 CFR 211.192)
Nov 3, 2017Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Cleaning SOPs/instructions (21 CFR 211.67(b)(3))
Calibration/Inspection/Checking not done (21 CFR 211.68(a))
Equipment construction - reactive surfaces (21 CFR 211.65(a))
and 3 more
Feb 12, 2016Voluntary Action Indicated (VAI)No citations listed
Aug 21, 2009No Action Indicated (NAI)No citations listed

FDA record score

35 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 OAIJul 10, 202630 x 130
Inspection classified VAIApr 19, 20236 x 0.63.6
Inspection classified VAINov 3, 20176 x 0.251.5
Inspection classified VAIFeb 12, 201610 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
Ormond Beach, FL (US)
Source
inspections

Import refusals

FDA data resources

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