FDA 483 - STYRAX LIFE SCIENCES PRIVATE LIMITED - June 07, 2024

This FDA Form 483 was issued to Styrax Life Sciences Pvt. Ltd., an API Intermediate Manufacturer in Anakapalli, following an inspection from June 3-7, 2024. The inspection revealed significant deficiencies in laboratory controls, specifically the failure to validate analytical methods for raw materials, in-process, and finished product testing. Additionally, the firm failed to perform identity testing on incoming raw materials used in manufacturing.