Indoco Remedies has received seven observations in Form 483 following a US Food and Drug Administration (US FDA) inspection of its Plant 2 (Sterile) manufacturing facility in Goa.

The inspection was conducted from August 27 to September 4, 2026, at the company’s Plant 2 (Sterile) facility in Goa. Upon conclusion of the inspection, the US FDA issued seven observations in Form 483.

Indoco Remedies said it is addressing the observations comprehensively and will submit its response to the US FDA within the stipulated timeframe.

Form 483 observations are issued by US FDA investigators when they identify conditions or practices that may indicate violations of regulatory requirements during an inspection. The issuance of Form 483 does not, by itself, represent a final regulatory determination.

Indoco Remedies operates 11 manufacturing facilities, including seven for Finished Dosage Forms (FDFs) and four for Active Pharmaceutical Ingredients (APIs), supported by a research and development centre and a Clinical Research Organisation (CRO) facility.

Its manufacturing facilities have received approvals from several regulatory authorities, including the USFDA and UK-MHRA. The company develops and manufactures a range of pharmaceutical products for the Indian and international markets and has a portfolio spanning therapeutic segments including gastro-intestinal, respiratory, anti-infectives, ophthalmic, cardiovascular, anti-diabetic, pain management and gynaecology.