FDA 483 - Indoco Remedies Limited - June 04, 2019

Indoco Remedies Limited in Vasco Da Gama, Goa, received a Form 483 with four observations primarily concerning deficiencies in stability testing and quality control procedures for drug products. Issues included out-of-specification results for expired batches, inadequate investigation scope, and a lack of robust written programs for stability assessment and in-process material examination. These findings indicate significant concerns regarding product quality assurance and compliance with manufacturing standards.