FDA 483 - Indoco Remedies Limited - June 04, 2019
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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.
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