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Lupin Limited, Pithampur, India – FDA Inspections

Inspection records and compliance data for Lupin Limited in Pithampur. 7 FDA inspections on record (3 OAI), 4 Form 483s, last inspected July 17, 2025.

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Company Profile

This profile covers Lupin Limited based in Pithampur, India.

FDA Inspection History

FDA inspections
7
OAI
3
VAI
1
NAI
1
Unclassified
2
Form 483s
4
Warning letters
0

First inspected November 18, 2009. Last inspected July 17, 2025.

Most cited issue areas

  • Investigations of discrepancies, failures2 inspections
  • Air Supply1 inspection
  • Computer control of master formula records1 inspection

FDA inspections (7)

DateResultFDA center(s)Insp. #
July 17, 2025Not classifiedHuman Drugs · Drug Quality Assurance1275446
March 29, 2023Not classifiedHuman Drugs1202053
January 25, 2019OAIHuman Drugs · Drug Quality Assurance1079307
May 19, 2017OAIHuman Drugs · Drug Quality Assurance1012540
January 23, 2015OAIHuman Drugs · Drug Quality Assurance911036
June 22, 2012NAIHuman Drugs · Drug Quality Assurance789247
November 18, 2009VAIHuman Drugs · Drug Quality Assurance636980
FDA documents

Form 483s (4)

  • Form 483s · July 17, 2025
  • Form 483s · March 29, 2023
  • Form 483s · January 25, 2019
  • Form 483s · May 19, 2017
People (6)
Darren S. Brown
Person
Tamil Arasu
Person
Yvlna Peran
Person
Jogy George
Person
Yvins Dezan
Person
Eileen A. Liu
Person
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Company Information

Name

Lupin Limited

FEI Number

3007549629

Address

Unit-2, Plot No. M-2 And M-2-A, Sez, Phase Ii, Misc. Zone, Apparel Park, Dist. Dhar, Pithampur, India

Country

India

ID: 8707ad63-3e60-4c11-9138-77be2a49865c

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