US FDA Issues Warning Letter to Palamur Biosciences Over 'Serious Violations'; PETA Moves PMO

Hyderabad: The United States’ Food and Drug Administration (FDA) has issued a public warning letter to Telangana-based animal testing laboratory and beagle breeder Palamur Biosciences Pvt. Ltd, citing “serious violations” of good laboratory practice regulations and warning that unreliable data generated at the facility “may put public health and safety at risk”.

This development has now prompted PETA India to seek intervention from both the Prime Minister’s Office and the Union ministry of animal husbandry.

“Another major international regulator has now said, in unmistakable terms, what whistleblowers and government-appointed inspectors in India have documented, that the animal welfare and other failures at Palamur Biosciences are systemic, entrenched, and dangerous,” said Dr Anjana Aggarwal, scientist and research policy advisor, PETA India.

The FDA warning letter, dated December 11, 2025, followed an inspection carried out in January 2025 by the agency’s office of bioresearch monitoring foreign inspection cadre. The regulator concluded that Palamur Biosciences committed “serious violations of Title 21, Code of Federal Regulations (CFR) Part 58”. They stated that these failures demonstrate “systemic failures in study director oversight of nonclinical laboratory studies and bring into question the quality and integrity of safety data collected at your testing facility”.

According to the FDA, deficiencies at the Mahbubnagar-based facility included poor or absent veterinary records, lack of documented health examinations before invasive procedures, unsatisfactory standard operating procedures, inadequate euthanasia practices that failed to ensure rapid unconsciousness, unsanitary housing conditions with animal droppings and pest harborage, and repeated failures by the quality assurance unit to detect or document deviations from approved protocols.

The FDA described Palamur’s responses to these findings as “inadequate’ and started that they “do not provide assurance that similar violations would not occur again”.

PETA India, in its representations dated January 13 to the Union animal husbandry ministry and on January 15 to the Prime Minister’s Office, argued that the FDA’s action corroborated a detailed inspection report submitted to India’s statutory animal experimentation regulator, the Committee for the Control and Supervision of Experiments on Animals (CCSEA), on June 17, 2025.

That inspection, carried out by a multidisciplinary committee appointed by the CCSEA itself, concluded that allegations of overcrowding, veterinary neglect, inappropriate handling, and euthanasia violations were either substantiated or could not be conclusively refuted due to missing documentation. The committee recommended immediate regulatory action, removal and rehabilitation of animals, and a review of Palamur’s registration and breeding licence.

Despite these findings, PETA India stated that no meaningful enforcement followed. Instead, the organisation alleged that subsequent inspections were conducted by active animal experimenters. In its letters, PETA India said the CCSEA had permitted delay, dilution, and cosmetic compliance, even as international regulators stepped in to flag risks to scientific integrity and public health.

The FDA warning letter is not the first international action against Palamur Biosciences. In May 2024, the United States Environmental Protection Agency temporarily stopped accepting studies from the company due to concerns over data falsification. The Canadian Pest Management Regulatory Agency took similar action in June 2024.

The representations detailed conditions at Palamur Biosciences, which houses more than 1,200 animals including beagles, pigs, monkeys, sheep, cattle, and rodents. Inspectors found no reliable written inventory of animals, with numbers exceeding permitted limits in some categories. Particular concern was raised over 73 beagles that Palamur claimed were under rehabilitation. Inspectors found that these dogs remained confined in laboratory conditions, with no written rehabilitation plans or evidence of recovery.

The June 2025 inspection material allegedly showed bleeding and dying beagles, pigs poisoned to the point of bleeding, frightened wild-caught monkeys, and untreated injuries. PETA India said the CCSEA acknowledged abuse only after they sent videogrpahic evidence.

In its letters, PETA India criticised the composition of the CCSEA Core Committee, which it said is dominated by representatives of animal experimentation institutions, despite the committee’s statutory mandate under the Prevention of Cruelty to Animals Act, 1960, to place animal welfare at the centre of its decisions.

“Allowing a conflicted committee dominated by animal experimenters to sit in judgment over animal welfare complaints is self-policing and a structural failure that harms animals, humans and India’s reputation on the global scale,” Dr Aggarwal said.