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•India

Intas Pharmaceuticals Limited, Ahmedabad, India – FDA Inspections

Inspection records and compliance data for Intas Pharmaceuticals Limited in Ahmedabad. 15 FDA inspections on record, 6 Form 483s, 1 warning letter, last inspected July 12, 2024.

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Company Profile

This profile covers Intas Pharmaceuticals Limited based in Ahmedabad, India.

FDA Inspection History

FDA inspections
15
OAI
0
VAI
9
NAI
1
Unclassified
5
Form 483s
6
Warning letters
1

First inspected November 13, 2009. Last inspected July 12, 2024.

Most cited issue areas

  • Environmental Monitoring System3 inspections
  • Absence of Written Procedures2 inspections
  • Equipment Design, Size and Location2 inspections

FDA inspections (15)

DateResultFDA center(s)Insp. #
July 12, 2024NAIHuman Drugs · Bioresearch Monitoring1245599
May 12, 2023Not classifiedHuman Drugs1206170
August 2, 2019VAIHuman Drugs · Drug Quality Assurance1098380
December 14, 2018VAIHuman Drugs · Generic Drug Evaluation1074349
August 17, 2018Not classifiedHuman Drugs1067525
June 8, 2018VAIAnimal Drugs & Feeds · Pre-Approval Eval. of Animal Drugs and Food Additives1056170
July 31, 2017Not classifiedHuman Drugs · New Drug Evaluation1021294
June 9, 2017Not classifiedHuman Drugs1023332
February 17, 2017Not classifiedHuman Drugs1005711
June 17, 2016VAIHuman Drugs · Drug Quality Assurance978469
April 7, 2015VAIHuman Drugs · Drug Quality Assurance923354
June 21, 2013VAIHuman Drugs · Drug Quality Assurance839384
May 19, 2012VAIHuman Drugs · Drug Quality Assurance788126
October 10, 2011VAIHuman Drugs · Drug Quality Assurance755788
November 13, 2009VAIHuman Drugs · Drug Quality Assurance634793
FDA documents

Form 483s (10)

  • Form 483s · February 14, 2025
  • Form 483s · January 24, 2024
  • Form 483s · December 7, 2023
  • Form 483s · May 12, 2023
  • Form 483s · December 2, 2022
  • Form 483s · August 2, 2019
  • Form 483s · December 14, 2018
  • Form 483s · June 8, 2018
  • Form 483s · July 31, 2017
  • Form 483s · February 17, 2017

Warning Letters (1)

  • Warning Letters · September 17, 2025
Other regulators (1)
  • UK MHRA · 5 inspections · last March 6, 2025
People (5)
Jose E. Melendez
Person
Justin A. Boyd
Person
Francis Godwin
Person
Yasamin Ameri
Person
Thomas J. Arista
Person
Related Companies (10)

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I 3 PHARMACEUTICALS, LLC
Pharmathen International S.A.
Mankind Pharma Limited
Eugia Pharma Specialities Limited
Takeda Pharmaceutical Company Limited
Company Information

Name

Intas Pharmaceuticals Limited

FEI Number

3003157498

Address

218p - Chacharwad, 458 - Matoda; Sarkhej Gandhi Nagar Highway, Ahmedabad, India

Country

India

ID: 0db00702-d7f6-4a8b-87d1-1b32ac236cc8

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