Home / Inspections / 1061339

1061339

QuestSpecialty Corporation — FEI 3002937340

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 3, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Brenham, TX (United States)

Facility

Other inspections at this facility

  • 1272491 (OAI Thu Jun 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015214 (VAI Thu Jun 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 735911 (NAI Fri Jul 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 657077 (VAI Wed Apr 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
126321 CFR 211.68(b)Computer control of master formula records
145021 CFR 211.113(a)Procedures for non-sterile drug products
188321 CFR 211.165(a)Testing and release for distribution
189021 CFR 211.165(e)Test methods
192821 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance