FDA 483 - Softgel Healthcare Private Limited - February 14, 2025

Softgel Healthcare Private Limited, a drug manufacturer in Kancheepuram District, India, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's quality system, including inadequate investigations, poor quality unit control over documents and data integrity, and a lack of appropriate validation and controls for computerized manufacturing systems. These issues indicate a systemic failure to ensure product quality and data reliability.