FDA EIR - Smilax Laboratories Limited - September 15, 2023

An FDA surveillance inspection of Smilax Laboratories Limited, a foreign non-sterile Active Pharmaceutical Ingredient (API) manufacturer in Vishakapatnam District, India, occurred from September 11 to September 15, 2023. This inaugural inspection, guided by regulatory frameworks including CP: #7356.002F and ICH Q7A for cGMP, assessed the company's Quality, Production, Laboratory Control, Material, and Facilities and Equipment systems. The primary violation identified was a deficiency in the firm's Quality system. Specifically, the company failed to adhere to its Standard Operating Procedure (SOP No. CQA008/03) for investigation and corrective and preventive action management, which required extending investigations to other potentially affected batches and products. This observation resulted in an FDA-483, Inspectional Observations, being issued. Smilax Laboratories Limited's Managing Director committed to implementing corrective actions and is required to submit a detailed written response within fifteen USA business days for FDA evaluation. The inspection's conclusion for this issue was classified as "Voluntary Action Indicated."