USFDA warning to Palamur Biosciences 

The USFDA issued a warning to Telangana’s Palamur Biosciences for serious Good Laboratory Practice violations, citing inhumane animal treatment and unreliable data. PETA India has urged government intervention, demanding rescue of 1,200 animals and reform of India’s experimentation regulator

Hyderabad: The United States Food and Drug Administration (FDA) has issued a public Warning Letter to Telangana-based Palamur Biosciences Pvt. Ltd., citing ‘serious violations’ of Good Laboratory Practices (GLP) and systemic failures that jeopardize the integrity of data safety used for global medical devices.

The USFDA letter (December 11, 2025), follows a January (last year) inspection of the Palamur Biosciences facility in Mahabubnagar. During the course of inspection, the investigators had documented a lack of basic veterinary care, missing health records for animals before invasive surgeries, and ‘inadequate and inhumane’ euthanasia procedures for rodents. The report specifically noted that the facility’s responses to these findings were “inadequate,” warning that unreliable data could put global public health at risk.

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Following the FDA’s warning, PETA India has written to the Prime Minister’s Office and the Union Minister for Animal Husbandry, urging immediate intervention. The PETA is calling for a total overhaul of Country’s statutory animal experimentation regulator,

CCSEA, arguing the body is compromised by a committee made up of the very experimenters it is supposed to regulate.

“The FDA has now confirmed what we have documented for months: these failures are systemic and dangerous,” said Dr. Anjana Aggarwal of PETA India. The group is demanding the rescue of 1,200 animals, including 73 beagles they say are being “caged for life” to hide their physical and psychological scars.

While an Indian government-appointed committee recommended the immediate “removal and rehabilitation” of over 1,200 animals last June, PETA India alleges that the domestic regulator, CCSEA, has yet to take definitive action.

The USFDA warning letter is available here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/palamur-biosciences-private-limited-708579-12112025