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FDA Inspection
•Lupin Limited•February 8, 2019

Lupin Limited – FDA Inspection, Feb 8, 2019

Record Details

This FDA Inspection record concerns Lupin Limited, with an inspection on February 8, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Lupin Limited
Inspection Date
February 8, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Lata C. Mathew
  • Unnee Ranjan (FDA Associated Person)
View Company Profile

ID · dc3721e8-c7f2-43b4-b548-6fdf0d276bba

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1078793
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

Other FDA inspections of Lupin Limited

10
DateClassificationOfficeProject area
November 21, 2025Not classifiedOffice of Inspections and Investigations
September 18, 2021VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 21, 2017Not classifiedOffice of Inspections and Investigations
April 7, 2017Not classifiedOffice of Inspections and Investigations
March 11, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 10 other inspections on the company page
Other documents for Lupin Limited
  • FDA Inspection 1290876 - 2025-11-21
  • FDA Inspection 1152219 - 2021-09-18
  • FDA Inspection 1025679 - 2017-07-21
  • FDA Inspection 1013797 - 2017-04-07
  • FDA Inspection 965791 - 2016-03-11

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