FDA 483 - Srikem Laboratories Pvt. Ltd. - May 31, 2024

Srikem Laboratories Pvt. Ltd., an API manufacturer in Navi Mumbai, India, was cited for significant deficiencies across its quality system, including inadequate documentation practices, scientifically unsound OOS investigations, and poor laboratory controls. Repeat observations highlight persistent issues with documentation and laboratory procedures, indicating a systemic lack of control over critical manufacturing and testing processes. The firm also failed to retain process validation documents and maintain facility cleanliness.