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906074

Anika Therapeutics, Inc. — FEI 3007093114

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 19, 2014
Fiscal Year
2015
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Bedford, MA (United States)

Facility

Other inspections at this facility

  • 1214830 (VAI Wed Aug 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1025975 (VAI Thu Sep 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 934403 (NAI Fri May 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 807026 (NAI Wed Nov 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 751866 (VAI Mon Oct 31 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
145121 CFR 211.113(b)Procedures for sterile drug products
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
358321 CFR 211.110(a)Written in-process control procedures
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.