Indoco Remedies' Goa Sterile Plant Gets 7 USFDA Form 483 Observations

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

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

Also Read: Indoco Remedies Secures EU GMP Certification for Goa Manufacturing Plant

Form 483 observations are issued by USFDA 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 Limited is a fully integrated, research-oriented pharmaceutical company headquartered in Mumbai, with a presence in international markets. According to the company's official information, it 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.

Also Read: USFDA successfully completes inspection at Indoco Remedies Mumbai API facility