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FDA Inspection
•Alembic Pharmaceuticals Limited (Units I and II)•May 31, 2025

Alembic Pharmaceuticals Limited (Units I and II) – FDA Inspection, May 31, 2025

Record Details

This FDA Inspection record concerns Alembic Pharmaceuticals Limited (Units I and II), with an inspection on May 31, 2025, issued by the Office of Inspections and Investigations, covering human drugs.

Company
Alembic Pharmaceuticals Limited (Units I and II)
Inspection Date
May 31, 2025
Product Type
Human Drugs
Office
Office of Inspections and Investigations
Person
  • Pratik S. Upadhyay (FDA Associated Person)
View Company Profile

ID · ba9076d1-2082-46d5-bc86-a9f09fe8f8d6

Inspection Facts

Inspection number
1270216
FDA center
Human Drugs
Outcome
Form 483 issued

Other FDA inspections of Alembic Pharmaceuticals Limited (Units I and II)

8
DateClassificationOfficeProject area
October 8, 2024NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
December 19, 2018Not classifiedOffice of Inspections and Investigations
April 23, 2018NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 29, 2016NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 18, 2013VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 8 other inspections on the company page
Other documents for Alembic Pharmaceuticals Limited (Units I and II)
  • FDA Inspection 1249881 - 2024-10-08
  • FDA Inspection 1076862 - 2018-12-19
  • FDA Inspection 1055013 - 2018-04-23
  • FDA Inspection 982077 - 2016-06-29
  • FDA Inspection 831397 - 2013-04-18

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