Alkem Laboratories Ltd., Bioequivalence Centre, Navi Mumbai, India – FDA Inspections

Inspection records and compliance data for Alkem Laboratories Ltd., Bioequivalence Centre in Navi Mumbai. 7 FDA inspections on record, last inspected May 08, 2026.

Company Profile

This profile covers Alkem Laboratories Ltd., Bioequivalence Centre based in Navi Mumbai, India.

FDA Inspection History

FDA inspections: 7
OAI: 0
VAI: 2
NAI: 3
Unclassified: 2
Form 483s: 0
Warning letters: 0

First inspected October 1, 2009. Last inspected May 8, 2026.

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
May 8, 2026	Not classified	Human Drugs	1320622
April 14, 2022	NAI	Human Drugs · Bioresearch Monitoring	1169830
October 18, 2019	NAI	Human Drugs · Bioresearch Monitoring	1110351
November 14, 2018	NAI	Human Drugs · Bioresearch Monitoring	1073451
July 14, 2017	Not classified	Human Drugs	1020170
May 9, 2014	VAI	Human Drugs · Drug Quality Assurance	880683
October 1, 2009	VAI	Human Drugs · Drug Quality Assurance	629513

FDA documents

No Form 483s, Warning Letters or EIRs on record.

Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Nisha Tushar Parikh, MBBS

GCS Medical College Hospital and Research Centre

KLES Dr. Prabhakar Kore Hospital and Medical Research Centre

Sushruta Multispeciality Hospital & Research Centre Pvt. Ltd.

Rajesh Parekh, M.S.

Lokmanya Holistic Cancer Care & Research Centre of (LMRC), Pune

Lotus Laboratories Pvt. Ltd.

Venu Gopal Jhanwar, M.D.

Oyster & Pearl Hospitals (ONP)

Department of Medical Oncology, VMMC & Safdarjung Hospital