FDA 483 - Sionc Pharmaceuticals Private Limited - November 15, 2024

An FDA inspection of Sionc Pharmaceuticals Private Limited, an Active Pharmaceutical Ingredient and Intermediate Manufacturer, was conducted from November 11 to November 15, 2024. The inspection resulted in an FDA Form 483, identifying significant concerns regarding the firm's equipment maintenance and qualification practices, which could compromise product quality and purity. Key observations highlighted that equipment used in production was not adequately maintained to prevent contamination.

Specifically, inspectors noted deteriorated and fraying gaskets on critical equipment, exposing internal components and potentially introducing chemical and microbiological contaminants into APIs and intermediates. There was no periodic evaluation system in place for these essential gaskets. Furthermore, the firm had not properly qualified its particulate removal systems, failing to ensure that various sized particulates generated during manufacturing operations were effectively removed from products. Additional deficiencies included numerous gouges on other gaskets and the inappropriate use of tape as a gasket material, which was found deteriorating and risked contaminating products with its remnants. These findings indicate a need for Sionc Pharmaceuticals to implement comprehensive corrective and preventive actions to ensure compliance with good manufacturing practices and prevent product contamination.