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976402

Troy Manufacturing, Inc. — FEI 3001451565

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 1, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hazle Township, PA (United States)

Facility

Other inspections at this facility

  • 1275066 (NAI Thu Jun 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079580 (VAI Thu Feb 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 819009 (VAI Tue Feb 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 678212 (VAI Mon Aug 30 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
202721 CFR 211.192Investigations of discrepancies, failures
240221 CFR 211.194(a)(5)Testing Calculations
358321 CFR 211.110(a)Written in-process control procedures
360321 CFR 211.160(b)Scientifically sound laboratory controls