FDA EIR - Inotiv Inc - December 02, 2021

Inotiv Inc. underwent an FDA inspection at its West Lafayette, IN facility from November 22 to December 2, 2021. This pre-announced inspection, conducted under Compliance Program 7348.808, specifically focused on the firm’s adherence to Good Laboratory Practice (GLP) regulations, 21 CFR Part 58. The company operates primarily as an analytical laboratory supporting pre-market applications. During the inspection, six GLP studies were reviewed, along with Standard Operating Procedures, sample receipt, handling, storage, and the validation of key computer systems including their LIMS and document control. Notably, the inspection concluded without the issuance of an FDA-483, indicating no significant regulatory violations were found. Two minor discussion points were presented to management. These included the need to ensure legibility of handwritten records, consistent with data integrity principles, and the importance of properly completing all third-party training forms. The firm demonstrated responsiveness, correcting one identified unsigned training form prior to the inspector's departure. This outcome reflects Inotiv Inc.'s generally strong compliance with GLP standards.