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793576

Twincraft Inc. — FEI 1219963

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 18, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Winooski, VT (United States)

Facility

Other inspections at this facility

  • 1268216 (NAI Tue Apr 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1127641 (VAI Tue Aug 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023785 (NAI Thu Aug 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 937989 (VAI Thu Jun 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 681544 (NAI Thu Sep 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
197521 CFR 211.182Written records kept in individual logs
354721 CFR 211.46(b)Equipment for Environmental Control
434521 CFR 211.160(b)(1)Samples (various types) representative, identified properly