Palamur Biosciences Faces USFDA Warning for Multiple GLP Compliance Failures
New Delhi: The United States Food and Drug Administration (USFDA) has issued a Warning Letter to Palamur Biosciences Private Limited, a preclinical contract research laboratory located in Mahabubnagar, Telangana, citing multiple serious violations of Good Laboratory Practice (GLP) regulations.
The warning follows an inspection conducted by the FDA’s Office of Bioresearch Monitoring between January 20 and January 27, 2025, to assess the company’s compliance with GLP requirements applicable to nonclinical laboratory studies. The inspection covered studies including implantation testing, acute systemic toxicity, material-mediated pyrogenicity and guinea pig maximization tests, which are critical for evaluating the safety of medical devices and related products.
In its findings, the FDA noted widespread non-compliance with 21 CFR Part 58, which governs GLP standards to ensure the integrity, reliability and quality of nonclinical safety data submitted to regulators. The agency stated that failures at the facility raised serious concerns about data credibility and oversight.
One of the key violations cited was the failure of the study director to ensure accurate documentation and verification of experimental data. Several study records were found to be incomplete, with missing information related to animal age, health status, dosing details, injection records and observations, undermining the reliability of the studies conducted.
The inspection also revealed that Palamur Biosciences did not maintain adequate standard operating procedures (SOPs) for critical study activities such as animal weighing, sample preparation and euthanasia. In addition, the management failed to ensure that personnel were properly trained and clearly understood their assigned responsibilities.
Deficiencies were also observed in the functioning of the Quality Assurance Unit (QAU). Deviations from approved study protocols were not consistently identified or documented, and oversight mechanisms were found to be ineffective. The FDA further noted concerns related to facility conditions, including unsanitary areas and pest presence, which could adversely affect study outcomes.
Although the company submitted written responses to the Form FDA-483 observations, the FDA concluded that these responses were inadequate. While revised SOPs and training records were provided, the responses lacked a comprehensive corrective and preventive action plan to address systemic issues and prevent recurrence.
According to the USFDA, the cumulative deficiencies indicate serious failures in study oversight and data integrity, calling into question the validity of nonclinical safety data generated at the facility and posing potential risks if such data are relied upon in regulatory submissions.
The FDA has directed Palamur Biosciences to submit a detailed written response within 15 working days, outlining specific corrective actions and measures to ensure future compliance. The agency warned that failure to adequately address the violations could result in further regulatory action, including possible disqualification from conducting GLP studies for FDA-regulated products.
