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Sun Pharmaceutical Medicare Limited, Halol, India – FDA Inspections

Inspection records and compliance data for Sun Pharmaceutical Medicare Limited in Halol. 7 FDA inspections on record, 4 Form 483s, last inspected September 19, 2025.

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Company Profile

This profile covers Sun Pharmaceutical Medicare Limited based in Halol, India.

FDA Inspection History

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

First inspected June 2, 2017. Last inspected September 19, 2025.

Most cited issue areas

  • Investigations of discrepancies, failures1 inspection
  • Written record of investigation incomplete1 inspection

FDA inspections (7)

DateResultFDA center(s)Insp. #
September 19, 2025Not classifiedHuman Drugs1288660
February 27, 2024NAIHuman Drugs · Drug Quality Assurance1231121
July 13, 2023VAIHuman Drugs · Drug Quality Assurance1210949
February 5, 2019NAIHuman Drugs · Drug Quality Assurance1078834
November 17, 2017Not classifiedHuman Drugs1037571
August 11, 2017Not classifiedHuman Drugs1025918
June 2, 2017NAIHuman Drugs · Drug Quality Assurance1018001
FDA documents

Form 483s (4)

  • Form 483s · September 19, 2025
  • Form 483s · February 27, 2024
  • Form 483s · July 13, 2023
  • Form 483s · February 5, 2019
People (5)
Tamil Arasu
Person
Andrew Le
Person
Anastasia M. Shields
Person
Feiyan Jin
Person
Junho Pak
Person
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Company Information

Name

Sun Pharmaceutical Medicare Limited

FEI Number

3002957541

Address

22 - 24 Village Ujeti, Post Baska; Survey No, Halol, India

Country

India

ID: bcde6f4d-9644-445c-b813-cb49ed881f97

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