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Palamur Biosciences Private Limited, a medical device testing facility in India, failed to comply with Good Laboratory Practice (GLP) regulations for nonclinical studies during an FDA inspection conducted January 20–27, 2025. The inspection by the FDA's Office of Bioresearch Monitoring Inspectorate identified objectionable conditions across multiple study types including implantation studies, acute systemic toxicity tests, material mediated pyrogenicity assays, and sensitization tests that support device development applications. These GLP violations are significant because the nonclinical data generated at the facility are submitted to support Investigational Device Exemptions, Premarket Approval applications, and Premarket Notifications for medical devices.