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Aurobindo Pharma Limited, Sangareddy, India – FDA Inspections

Inspection records and compliance data for Aurobindo Pharma Limited in Sangareddy. 5 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected September 29, 2023.

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Company Profile

This profile covers Aurobindo Pharma Limited based in Sangareddy, India.

FDA Inspection History

FDA inspections
5
OAI
1
VAI
3
NAI
1
Form 483s
1
Warning letters
1

First inspected December 22, 2010. Last inspected September 29, 2023.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Approve or reject components, products1 inspection
  • Cleaning / Sanitizing / Maintenance1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
September 29, 2023VAIHuman Drugs · Drug Quality Assurance1219023
September 1, 2017VAIHuman Drugs · Drug Quality Assurance1028769
December 9, 2014NAIHuman Drugs · Drug Quality Assurance909414
September 21, 2012VAIHuman Drugs · Drug Quality Assurance800619
December 22, 2010OAIHuman Drugs · Drug Quality Assurance711843
FDA documents

Form 483s (2)

  • Form 483s · September 29, 2023
  • Form 483s · September 1, 2017

Warning Letters (1)

  • Warning Letters · February 9, 2019
People (4)
Robert M. Barbosa
Person
Francis Godwin
Person
Brandy N. Lepage
Person
Jennifer L. Huntington
Person
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Lilly del Caribe, Inc
Sun Pharmaceutical Industries Ltd.
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MSN Laboratories Private Limited
Company Information

Name

Aurobindo Pharma Limited

FEI Number

3004021263

Address

Unit-VI, Chitkul Village, Patancheru Mandal, Sy. No.329/39 & 329/47, Sangareddy, India

Country

India

ID: 526fd1b4-90b1-4e91-b9f5-a3eab997ed60

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