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Alembic Pharmaceuticals Limited, India – FDA Inspections

Inspection records and compliance data for Alembic Pharmaceuticals Limited. 1 FDA inspection on record, 1 Form 483, last inspected November 22, 2024.

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Company Profile

This profile covers Alembic Pharmaceuticals Limited based in India.

FDA Inspection History

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

Inspected November 22, 2024.

Most cited issue areas

  • Acceptance criteria for sampling & testing1 inspection
  • Cleaning SOP/inspection1 inspection
  • Control procedures to monitor and validate performance1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
November 22, 2024VAIHuman Drugs · Drug Quality Assurance1254771
FDA documents

Form 483s (4)

  • Form 483s · November 22, 2024
  • Form 483s · December 16, 2022
  • Form 483s · August 30, 2022
  • Form 483s · November 10, 2021
Other regulators (1)
  • UK MHRA · 1 inspection · last July 21, 2014
People (5)
Kellia N. Hicks
Person
Yvins Dezan
Person
Kellie B. Kelm
Person
Matthew B. Casale
Person
Marcellinus D. Dordunoo
Person
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Company Information

Name

Alembic Pharmaceuticals Limited

FEI Number

3016088083

Address

India

Country

India

ID: 312ff75c-8a88-40fe-a7a6-52fa52c791cb

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