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657077

QuestSpecialty Corporation — FEI 3002937340

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 14, 2010
Fiscal Year
2010
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))
  • 1061339 (VAI Fri Aug 03 2018 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))

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
126321 CFR 211.68(b)Computer control of master formula records
191221 CFR 211.166(a)Written program not followed
194321 CFR 211.180(e)(1)Review of representative number of batches
200921 CFR 211.188Prepared for each batch, include complete information
432821 CFR 211.122(a)Written procedures not followed