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1295786

Wyeth Pharmaceutical Division of Wyeth Holdings LLC — FEI 2410662

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 17, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pearl River, NY (United States)

Facility

Other inspections at this facility

  • 1237528 (VAI Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1168201 (VAI Wed Apr 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 804865 (VAI Wed Oct 24 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 791692 (NAI Wed Jul 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 597355 (NAI Wed Jul 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145221 CFR 211.113(b)Validation lacking for sterile drug products
180321 CFR 211.84(b)Representative Samples Criteria
239921 CFR 211.194(a)(2)Laboratory Test Method Verification
432021 CFR 211.84(d)(6)Microbiological Contamination Exam