Wyeth Pharmaceutical Division Of Wyeth Holdings LLC FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection VAI · Apr 23, 2026
  • No warning letters matched by name
Inspections 17 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Wyeth Pharmaceutical Division Of Wyeth Holdings LLC has 0 FDA recalls, 17 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Wyeth Pharmaceutical Division Of Wyeth Holdings LLC" is on file.

What these totals cover: FDA records filed under the name "Wyeth Pharmaceutical Division Of Wyeth Holdings LLC" and its spelling variant "Wyeth Pharmaceutical Division Of Wyeth Holdings". Records filed under related names are not included; see Related names.

Latest recall
D-0052-2027 · Sep 29, 2026 · filed under Pfizer
Latest inspection
Apr 23, 2026 · VAI

Newer recall under related name Pfizer: Sep 29, 2026, D-0052-2027.

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections17Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Wyeth Pharmaceutical Division Of Wyeth Holdings LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Wyeth Pharmaceutical Division Of Wyeth Holdings LLC: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202510000
202420000
202300000
202220000
202100000
202000000
201910000
201810000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

17 inspections from Oct 8, 2008 to Apr 23, 2026.

DateSiteProductClassificationFEI
Apr 23, 2026Sanford, NCBiologicsVoluntary Action Indicated (VAI)1000110954
Dec 17, 2025Pearl River, NYDrugsVoluntary Action Indicated (VAI)2410662
Oct 17, 2024Sanford, NCBiologicsVoluntary Action Indicated (VAI)1000110954
Aug 28, 2024Pearl River, NYDrugsVoluntary Action Indicated (VAI)2410662
Nov 18, 2022Sanford, NCBiologicsVoluntary Action Indicated (VAI)1000110954
Apr 13, 2022Pearl River, NYDrugsVoluntary Action Indicated (VAI)2410662
Nov 26, 2019Sanford, NCBiologicsVoluntary Action Indicated (VAI)1000110954
Apr 19, 2018Sanford, NCBiologicsVoluntary Action Indicated (VAI)1000110954
Aug 18, 2016Sanford, NCBiologicsVoluntary Action Indicated (VAI)1000110954
Jul 23, 2014Sanford, NCBiologicsVoluntary Action Indicated (VAI)1000110954
Oct 24, 2012Pearl River, NYBiologicsVoluntary Action Indicated (VAI)2410662
Jul 18, 2012Pearl River, NYFood/CosmeticsNo Action Indicated (NAI)2410662
Nov 18, 2011Sanford, NCBiologicsVoluntary Action Indicated (VAI)1000110954
Feb 28, 2011Sanford, NCDrugsNo Action Indicated (NAI)1000110954
Dec 11, 2009Sanford, NCBiologicsVoluntary Action Indicated (VAI)1000110954
Jul 1, 2009Pearl River, NYBiologicsNo Action Indicated (NAI)2410662
Oct 8, 2008Pearl River, NYFood/CosmeticsVoluntary Action Indicated (VAI)2410662
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1000110954Sanford, NC10Apr 23, 2026
FEI 2410662Pearl River, NY7Dec 17, 2025

Wyeth Pharmaceutical Division Of Wyeth Holdings LLC and the FDA: common questions

Has Wyeth Pharmaceutical Division Of Wyeth Holdings LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Wyeth Pharmaceutical Division Of Wyeth Holdings LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Wyeth Pharmaceutical Division Of Wyeth Holdings LLC received an FDA Form 483?

FDA has not published a Form 483 for "Wyeth Pharmaceutical Division Of Wyeth Holdings LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Wyeth Pharmaceutical Division Of Wyeth Holdings LLC?

The most recent FDA inspection on file ended Apr 23, 2026 at Sanford, NC and was classified VAI. FDA has 17 inspections of Wyeth Pharmaceutical Division Of Wyeth Holdings LLC on file.

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