FDA 483 - Global Calcium Pvt. Limited - February 03, 2026

An FDA inspection of Global Calcium Pvt. Limited, an Active Pharmaceutical Ingredient manufacturer in Hosur, India, revealed significant deficiencies in laboratory controls, data integrity, and quality unit responsibilities. Findings included unreliable microbiology data, failure to follow sampling procedures, inadequate Bacterial Endotoxin Test conditions, and non-reproducible cleaning processes. The firm's quality system was found ineffective in preventing data integrity breaches, and a committed retrospective assessment was not comprehensively performed.