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FDA Inspection 1097269 — Somerset Therapeutics Private Limited

Somerset Therapeutics Private Limited — FEI 3003821988

The FDA completed an inspection of Somerset Therapeutics Private Limited on July 23, 2019 in Bengaluru. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 23, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bengaluru (India)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed

Facility

Other inspections at this facility

  • 1261727 (OAI Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1226714 (VAI Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1166834 (OAI Mon Apr 04 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118121 (OAI Wed Feb 19 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1038093 (VAI Tue Dec 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources