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678212

Troy Manufacturing, Inc. — FEI 3001451565

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 30, 2010
Fiscal Year
2010
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))
  • 976402 (VAI Wed Jun 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 819009 (VAI Tue Feb 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
135821 CFR 211.100(b)SOPs not followed / documented
202021 CFR 211.188(b)(8)Labeling Control Records and Label Copies
358521 CFR 211.110(a)Control procedures to monitor and validate performance
441321 CFR 211.194(a)(8)Second person sign off