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1054535

Pekana Naturheilmittel GmbH — FEI 3002037061

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 1, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Kislegg (Germany)

Facility

Other inspections at this facility

  • 1302516 (VAI Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1156199 (VAI Thu Jul 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981424 (VAI Fri May 06 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 826409 (VAI Fri Mar 08 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 542411 (VAI Thu Oct 02 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
149521 CFR 211.122(a)Written procedures describing in detail
172821 CFR 211.87Retest of approved components/containers/closures
360321 CFR 211.160(b)Scientifically sound laboratory controls