FDA 483 - Althera Laboratories India Private Limited - March 14, 2020

Althera Laboratories India Private Limited in Bangalore, India, was cited for significant deficiencies in its method validation laboratory during an FDA inspection. The firm failed to conduct thorough investigations into laboratory discrepancies, maintain adequate documentation for test procedures, and ensure proper controls over computer systems and data accuracy. These issues indicate a lack of robust quality control and data integrity practices.