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895238

Merck Sharp & Dohme LLC — FEI 2510592

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 12, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
West Point, PA (United States)

Facility

Other inspections at this facility

  • 1252348 (NAI Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229927 (VAI Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155052 (VAI Tue Jul 27 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1103540 (VAI Fri Sep 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 938141 (VAI Fri Apr 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
434321 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
435321 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
440621 CFR 211.194(a)(2)Suitability of testing methods verified