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1061011

Anicare Pharmaceuticals Pvt Ltd. — FEI 3007450508

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 3, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Navi Mumbai (India)

Facility

Other inspections at this facility

  • 1195342 (OAI Fri Jan 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 978860 (VAI Thu Jul 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
178721 CFR 211.80(a)Procedures To Be in Writing
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
358521 CFR 211.110(a)Control procedures to monitor and validate performance
358821 CFR 211.110(a)(3)Mixing adequacy
440621 CFR 211.194(a)(2)Suitability of testing methods verified