Unichem Labs Pithampur facility gets USFDA EIR

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-05-14T17:39:53+05:30 | Updated On 14 May 2025 5:39 PM IST

Mumbai: Unichem Labs has announced that United States Food and Drug Administration (USFDA) has classified the inspection at the Company's Pithampur API facility as Voluntary Action Initiated ("VAI") and issued the Establishment Inspection Report (EIR).

The facility was inspected from 24th February 2025 to 28th February 2025. In March, the facility had initially received four observations from the USFDA.

Voluntary Action Indicated (VAI) classification indicates the inspection found objectionable conditions or practices but the agency has determined the facility can voluntarily correct its deficiencies and will not recommend any action.

Headquartered in Mumbai, Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. The company was founded in 1944 by Padmabhushan Late Mr. Amrut V Mody. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751