FDA 483 - Shriram Institute for Industrial Research - February 29, 2024

An FDA inspection of Shriram Institute for Industrial Research, a control testing laboratory in Delhi, India, was conducted from February 26 to 29, 2024. The inspection revealed significant and recurring deficiencies in the firm's quality systems and laboratory operations, indicating a failure to adhere to Current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP). Key observations included the lack of properly documented and followed quality control unit procedures. The firm's electronic laboratory records and instrument validation were deemed unreliable, with an absence of Performance Qualification for instruments and inadequate computer system validation for critical analytical equipment. Furthermore, the suitability of testing methods was not adequately verified under actual conditions of use, and a concerning instance of shredded quality documents was noted. The facility also failed to thoroughly investigate unexplained discrepancies, such as invalid lab results or temperature excursions, and neglected to address customer complaints effectively. Finally, employee training in cGMP/GLP was found to be insufficient, lacking defined frequency and comprehensive content. These observations necessitate immediate and comprehensive corrective actions to bring the laboratory into compliance with regulatory standards for drug product testing.