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Wyeth Pharmaceutical Division Of Wyeth Holdings LLC FDA Inspection Record

FEI 2410662 · Inspections, Form 483s, warning letters and import refusals

Wyeth Pharmaceutical Division Of Wyeth Holdings LLC is an FDA-inspected facility (FEI 2410662) located in Pearl River, NY, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Dec 17, 2025: Voluntary Action Indicated (VAI)
Inspections on record
7 (5 VAI, 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
Form 483 and inspection documents
1 in FDA's reading room

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
Dec 17, 2025Voluntary Action Indicated (VAI)Validation lacking for sterile drug products (21 CFR 211.113(b))
Representative Samples Criteria (21 CFR 211.84(b))
Laboratory Test Method Verification (21 CFR 211.194(a)(2))
Microbiological Contamination Exam (21 CFR 211.84(d)(6))
Aug 28, 2024Voluntary Action Indicated (VAI)No citations listed
Apr 13, 2022Voluntary Action Indicated (VAI)No citations listed
Oct 24, 2012Voluntary Action Indicated (VAI)No citations listed
Jul 18, 2012No Action Indicated (NAI)No citations listed
Jul 1, 2009No Action Indicated (NAI)No citations listed
Oct 8, 2008Voluntary Action Indicated (VAI)No citations listed

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Jul 24, 2015, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.

FDA record score

13 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.

5 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIDec 17, 20256 x 16
Inspection classified VAIAug 28, 20246 x 0.63.6
Inspection classified VAIApr 13, 20226 x 0.63.6
Inspection classified VAIOct 24, 201210 years or older, so it adds no points0
Inspection classified VAIOct 8, 200810 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 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Wyeth Pharmaceutical Division Of Wyeth Holdings LLC
Location
Pearl River, NY (US)
Source
inspections

FDA data resources

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