FDA 483 - INVITRO RESEARCH SOLUTIONS PRIVATE LIMITED - December 18, 2025

From December 15 to December 18, 2025, the FDA inspected Invitro Research Solutions Private Ltd, a control testing laboratory located in Bengaluru, India. The inspection identified several significant failures in the facility’s quality management systems and laboratory documentation practices. Primary violations included the omission of failed test results from official method validation reports, particularly concerning impurity testing for active pharmaceutical ingredients. When failures did occur, the firm’s investigations were found to be insufficient, lacking root cause analysis and often occurring only after re-analysis had already been performed. Additionally, the firm lacked robust written procedures for critical operations. Specific issues included the use of unvalidated Excel spreadsheets for complex calculations, a lack of strict acceptance criteria for analytical standards, and failing to coordinate test method changes with application sponsors. The inspection also highlighted that the firm’s stability testing program was unreliable, as it failed to prove that testing methods could accurately distinguish specific impurities from other degradation products in finished drugs. These findings indicate that the laboratory’s processes do not currently meet the necessary standards to ensure the identity, strength, and purity of the products tested. The company is expected to respond to these observations with a detailed plan for corrective and preventive actions to bring their laboratory operations into compliance with regulatory expectations.