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820634

Haleon US Inc. — FEI 1911445

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 14, 2013
Fiscal Year
2013
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
186821 CFR 211.94(b)Protection from external factors
191421 CFR 211.166(a)Lack of written stability program
194321 CFR 211.180(e)(1)Review of representative number of batches
202821 CFR 211.192Extent of discrepancy, failure investigations
241921 CFR 211.198(a)Complaint Handling Procedure
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
440221 CFR 211.192Written record of investigation incomplete
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications