FDA 483 - Tianish Laboratories Private Limited - April 25, 2025

An FDA inspection conducted from April 21-25, 2025, at Tianish Laboratories Private Limited in Hyderabad, Telangana, India, identified significant quality control deficiencies in their Active Pharmaceutical Ingredient (API) manufacturing. The inspection, detailed in an FDA Form 483, presented two primary observations. Firstly, the company failed to perform adequate onsite identity testing for numerous raw materials used in API production for the U.S. market. Tianish Laboratories relied solely on supplier certificates of analysis without independent validation, contrary to their own Standard Operating Procedures requiring such testing. This practice compromises the assurance of starting material integrity. Secondly, manufacturing equipment was not consistently identified or documented on batch records. Critical product contact parts, intended for disposal and replacement during product changeovers, lacked unique identification numbers, hindering verification of proper replacement. Furthermore, unknown material stains were observed on product contact surfaces, and the firm lacked scientific data to justify the reuse of certain equipment components for multiple batches, raising concerns about product quality and potential cross-contamination. To achieve compliance with good manufacturing practices, Tianish Laboratories must implement comprehensive corrective actions, including robust raw material testing protocols, ensuring unique identification and tracking of equipment, and validating equipment cleaning and usage limits. These actions are vital for ensuring the safety and quality of APIs produced for the U.S. market.