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1280192

EMS Acquisition Corp — FEI 2510480

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 24, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Morgantown, PA (United States)

Facility

Other inspections at this facility

  • 1175240 (VAI Fri Jul 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 947578 (VAI Thu Oct 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 815025 (NAI Thu Jan 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 546322 (VAI Thu Nov 06 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
188521 CFR 211.165(b)Microbiological testing
356721 CFR 211.84(d)(2)Component identification test