Cadila Pharmaceuticals Limited – FDA 483, May 10, 2024

Cadila Pharmaceuticals Limited, an API drug manufacturer in Ankleshwar, India, was cited for significant deficiencies across laboratory controls, manufacturing equipment validation, and quality control documentation. Issues included inadequate water system monitoring for microbial contamination, unvalidated equipment usage, and a lack of written procedures for document disposal. These findings indicate a moderate level of severity regarding quality system compliance.