FDA 483 - Encube Ethicals Pvt. Ltd. - June 11, 2019

Encube Ethicals Pvt. Ltd. in Ponda, India, a topical contract manufacturer, was cited for significant deficiencies in its laboratory controls, equipment maintenance, and complaint handling during an FDA inspection. Observations included inadequate OOS investigations, improper storage of reference standards, incomplete laboratory records, and a failure to thoroughly investigate customer complaints, indicating systemic issues with quality control and documentation.