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Ipca Laboratories Limited, Silvassa, India – FDA Inspections

Inspection records and compliance data for Ipca Laboratories Limited in Silvassa. 5 FDA inspections on record (2 OAI), 2 Form 483s, last inspected April 26, 2023.

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Company Profile

This profile covers Ipca Laboratories Limited based in Silvassa, India.

FDA Inspection History

FDA inspections
5
OAI
2
VAI
3
NAI
0
Form 483s
2
Warning letters
0

First inspected May 28, 2010. Last inspected April 26, 2023.

Most cited issue areas

  • Adverse Drug Experience1 inspection
  • Batch production and Batch Control Record Requirements1 inspection
  • Cleaning SOPs/instructions1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
April 26, 2023VAIHuman Drugs · Drug Quality Assurance1205137
August 23, 2019OAIHuman Drugs · Drug Quality Assurance1100388
December 19, 2014OAIHuman Drugs · Drug Quality Assurance909724
July 31, 2012VAIHuman Drugs · Drug Quality Assurance792946
May 28, 2010VAIHuman Drugs · Drug Quality Assurance670814
FDA documents

Form 483s (3)

  • Form 483s · April 26, 2023
  • Form 483s · August 23, 2019
  • Form 483s
People (6)
Parul M. Patel
Person
James C. Maclaughlin
Person
Pratik S. Upadhyay
Person
Arsen Karapetyan
Person
Kellia N. Hicks
Person
Rajiv R. Srivastava
Person
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Company Information

Name

Ipca Laboratories Limited

FEI Number

3005977675

Address

99 Plot No 65, And 126, Silvassa, India

Country

India

ID: 4221e8f5-a261-45fc-b9fc-d935bc1f225b

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Contact
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