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1127641

Twincraft Inc. — FEI 1219963

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 25, 2020
Fiscal Year
2020
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))
  • 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))
  • 793576 (VAI Wed Jul 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 681544 (NAI Thu Sep 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
137121 CFR 211.101(a)Batches Formulated to less than 100%
145021 CFR 211.113(a)Procedures for non-sterile drug products
240521 CFR 211.194(a)(7)Identification of Person Performing the Testing
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
441321 CFR 211.194(a)(8)Second person sign off