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1021515

Hawthorne Products, Inc — FEI 1824900

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 11, 2017
Fiscal Year
2017
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Dunkirk, IN (United States)

Facility

Other inspections at this facility

  • 1271965 (VAI Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 856394 (VAI Tue Nov 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 769028 (VAI Wed Jan 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 605506 (VAI Mon Aug 17 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
122721 CFR 211.67(c)Cleaning/maintenance records not kept
141121 CFR 211.105(b)Distinctive ID or code not recorded in batch record
144821 CFR 211.111Establishment of time limitations
154621 CFR 211.125(d)Destruction of excess labels with lot numbers
202621 CFR 211.192Quality control unit review of records
356721 CFR 211.84(d)(2)Component identification test
360321 CFR 211.160(b)Scientifically sound laboratory controls
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
438921 CFR 211.198(a)Procedures to be written and followed
439121 CFR 211.180(e)(2)Items to cover on annual reviews
441321 CFR 211.194(a)(8)Second person sign off