FDA 483 - Salicylates & Chemicals Private Ltd. - February 09, 2024

Salicylates & Chemicals Private Ltd., an API manufacturer in Hyderabad, India, was cited for significant quality system deficiencies. Observations included inadequate investigations into laboratory deviations, a lack of proper audit trail functions and data integrity controls for computerized systems, and the absence of method verification studies for USP pharmacopoeia analytical methods. These issues indicate a lack of robust quality control and data management practices.