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Aurobindo Pharma Ltd, Medchal, India – FDA Inspections

Inspection records and compliance data for Aurobindo Pharma Ltd in Medchal. 12 FDA inspections on record (1 OAI), 4 Form 483s, last inspected July 21, 2023.

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Company Profile

This profile covers Aurobindo Pharma Ltd based in Medchal, India.

FDA Inspection History

FDA inspections
12
OAI
1
VAI
7
NAI
4
Form 483s
4
Warning letters
0

First inspected January 30, 2009. Last inspected July 21, 2023.

Most cited issue areas

  • Complete test data included in records2 inspections
  • Procedures not in writing, fully followed2 inspections
  • Written procedures not established/followed2 inspections

FDA inspections (12)

DateResultFDA center(s)Insp. #
July 21, 2023VAIHuman Drugs · Drug Quality Assurance1210950
July 5, 2019VAIHuman Drugs · Drug Quality Assurance1155879
May 24, 2019VAIHuman Drugs · Drug Quality Assurance1090627
August 10, 2018VAIHuman Drugs · Postmarket Surv. and Epidemiology1061698
April 18, 2017VAIHuman Drugs · Drug Quality Assurance1010385
January 29, 2016NAIHuman Drugs · Drug Quality Assurance960797
June 26, 2015VAIHuman Drugs · Drug Quality Assurance940768
March 2, 2012NAIHuman Drugs · Drug Quality Assurance774770
September 8, 2011VAIHuman Drugs · Drug Quality Assurance750125
September 24, 2010OAIHuman Drugs · Drug Quality Assurance684552
October 22, 2009NAIHuman Drugs · Drug Quality Assurance636499
January 30, 2009NAIHuman Drugs · Drug Quality Assurance572925
FDA documents

Form 483s (4)

  • Form 483s · July 21, 2023
  • Form 483s · May 24, 2019
  • Form 483s · December 14, 2018
  • Form 483s · April 18, 2017
People (5)
Angela Glenn
Person
Cheryl A. Clausen
Person
Jose A. Cruz Gonzalez
Person
Rajesh Kulkarni
Person
Arsen Karapetyan
Person
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Company Information

Name

Aurobindo Pharma Ltd

FEI Number

3004021229

Address

Unit 3, Survey 313 & 314, Bachupally, Medchal-Malkajgiri District, Medchal, India

Country

India

ID: 169fdedf-28b5-446b-84f4-65ca9bc54a1a

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