FDA 483 - Styrax Life Sciences Pvt. Ltd. - June 07, 2024

An FDA inspection conducted at Styrax Life Sciences Pvt. Ltd., an API Intermediate Manufacturer, from June 3 to June 7, 2024, resulted in the issuance of a Form FDA 483, highlighting significant observations concerning quality control practices. The primary finding noted the company's failure to validate numerous analytical methods. These unvalidated methods were extensively used for testing and releasing raw materials, in-process materials, and finished API intermediates, including procedures for identification, water content, HPLC assay, and purity. This directly impacts the ability to reliably determine product conformance to specifications. Additionally, inspectors observed that the firm did not perform adequate identity testing for raw materials upon receipt. The company's receiving procedures lacked specific identification tests for components used in manufacturing API intermediates, leading to the use of untested materials in production. These observations indicate that Styrax Life Sciences Pvt. Ltd. must implement comprehensive corrective and preventive actions to ensure compliance with regulatory requirements, specifically by validating all analytical methods and establishing robust raw material identity verification processes.