FDA WARNING_LETTER - LOKA BIOSCIENCES PRIVATE LIMITED - January 27, 2025

The FDA issued a Warning Letter to Palamur Biosciences Private Limited (PBS) on December 11, 2025, following an inspection conducted from January 20 to January 27, 2025. The inspection identified serious violations of Title 21, Code of Federal Regulations (CFR) Part 58, which outlines Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies related to medical device development. The primary issue highlighted was the study director"s failure to ensure accurate recording and verification of experimental data. Specific examples included untraceable animal age records for an implantation study, the absence of recorded intravenous administration rates for acute systemic toxicity and material mediated pyrogenicity studies (preventing verification against ISO 10993/USP Chapter 151 guidelines), and a lack of physical examination records for animals at the start of another study. These deficiencies raise concerns about the quality and integrity of data used in premarket submissions, potentially impacting public health. Although PBS provided several responses to the FDA"s observations, the agency deemed them inadequate due to the absence of planned preventive actions like audit schedules or future staff training. The FDA requires prompt corrective action to address these significant GLP violations and ensure the reliability of all future study data.