FDA 483 - Encube Ethicals Pvt. Ltd. - June 17, 2024

An FDA inspection of Encube Ethicals Private Limited, a topical manufacturer in Ponda, Goa, India, revealed numerous significant deficiencies across its quality system, facilities, equipment, material handling, production, and laboratory controls. The firm failed to adequately investigate out-of-specification results, lacked established procedures for critical manufacturing processes and equipment, and exhibited poor documentation practices. These issues indicate a systemic lack of control over manufacturing and quality operations, potentially impacting product quality and patient safety.