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941497

King Bio Inc. — FEI 1053442

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 4, 2015
Fiscal Year
2015
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Asheville, NC (United States)

Facility

Other inspections at this facility

  • 1215129 (VAI Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1149278 (VAI Thu Aug 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1059419 (OAI Fri Jul 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1004463 (VAI Thu Mar 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 900797 (NAI Wed Oct 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
121521 CFR 211.67(b)Written procedures not established/followed
126621 CFR 211.42(d)Penicillin processing area not kept separate
140921 CFR 211.42(c)(4)In-Process Material Area
191421 CFR 211.166(a)Lack of written stability program
192421 CFR 211.166(a)(5)Testing of reconstituted drugs
197821 CFR 211.182Personnel dating/signing equipment log
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
355121 CFR 211.46(d)Penicillin air handling systems not kept separate
360321 CFR 211.160(b)Scientifically sound laboratory controls
362321 CFR 211.170(a)Active ingredient retained sample kept
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
436421 CFR 211.176Failing to test for penicillin cross-contamination
441321 CFR 211.194(a)(8)Second person sign off