FDA Inspection 1079090 — Shilpa Medicare Limited

Shilpa Medicare Limited — FEI 3010619401

The FDA completed an inspection of Shilpa Medicare Limited on Feb 13, 2019 in Bengaluru. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Feb 13, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bengaluru (India)

Citations

IDCFRDescription
181021 CFR 211.160(a)Lab controls established, including changes

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