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763095

Haleon US Inc. — FEI 1911445

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 20, 2012
Fiscal Year
2012
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Lincoln, NE (United States)

Facility

Other inspections at this facility

  • 1229361 (NAI Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1153381 (VAI Thu Sep 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117667 (NAI Wed Dec 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1013216 (NAI Thu May 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1008528 (NAI Wed Feb 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
113621 CFR 211.25(c)Inadequate number of personnel
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
202821 CFR 211.192Extent of discrepancy, failure investigations
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
438921 CFR 211.198(a)Procedures to be written and followed
439121 CFR 211.180(e)(2)Items to cover on annual reviews
440221 CFR 211.192Written record of investigation incomplete
890621 CFR 314.81(b)(1)(i)Mix-up