Ipca Labs receives 3 USFDA observations for Tarapur facility

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-12-05 09:36 GMT | Update On 2025-12-05 09:36 GMT

Mumbai: Ipca Labs has announced that the U.S. Food and Drug Administration (USFDA) has concluded inspection with three observations at the Company’s Active Pharmaceutical Ingredients (APIs) manufacturing facility situated at Tarapur (Palghar Maharashtra).

The inspection was conducted from 1st December, 2025 to 5th December, 2025.

At the conclusion of the inspection, US FDA has issued a Form 483 with 3 (three) observations.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

"The Company will submit its comprehensive response on these observations to the US FDA within the stipulated time and shall work closely with the agency to resolve these issues at the earliest,"

Ipca stated in a BSE filing.

"The Company takes the quality and compliance issues with utmost importance and remains committed to maintain the highest standards of quality and compliance across all its manufacturing facilities," it added.

Read also: Ipca Labs incorporates new wholly owned arm in Federal Republic of Germany

Established in 1949, lpca is a pharmaceutical company. lpca is vertically integrated and produces finished dosage forms and active pharmaceutical ingredients. For more than 70 years, lpca has been a crucial healthcare partner in over 120 countries across the globe. lpca markets its branded formulations in India and rest of the world markets and generic formulations in United States, Europe, United Kingdom, Canada, Australia & New Zealand. APls manufactured by lpca are marketed across the globe.

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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

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Ipca Labs receives 3 USFDA observations for Tarapur facility

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