Smilax Laboratories LimitedSeptember 11, 2023

FDA 483 - Smilax Laboratories Limited - September 11, 2023

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Record Details

An FDA inspection of Smilax Laboratories Limited in Parawada-Vishakapatnam, India, an Active Pharmaceutical Ingredient Manufacturer, revealed a significant issue with the firm's investigation and corrective and preventive action management. The firm failed to follow its own SOP, specifically by not extending investigations to other potentially affected batches and products following complaints of foreign particles and dead insects.

Company: Smilax Laboratories Limited
Inspection Date: September 11, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Luis A. Carrion (investigator)

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ID · 2f1966eb-d6d5-4b0d-80d7-c38f349fecae