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FDA Shuts Blood Banks in Pune Over Safety Violations

Desk_dcn by Desk_dcn
April 14, 2025
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FDA Shuts Blood Banks in Pune Over Safety Violations
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Pune: The Food and Drug Administration (FDA) has launched a stringent inspection campaign targeting blood banks and storage facilities in the Pune division, resulting in the cancellation of three licenses and suspension of 48 others for serious legal and safety breaches. The inspections, which took place between April 2024 and March 2025, uncovered multiple violations across the region.

The Pune division—comprising the districts of Pune, Solapur, Satara, Kolhapur, and Sangli—recorded a high number of infractions, with Pune district alone responsible for over 70% of the total cases, according to officials.

Out of 205 blood banks and storage centers assessed during the year, many were found flouting key regulations under the Drugs and Cosmetics Act, 1940. Infractions included unsafe storage of blood and its components, unhygienic conditions, lack of qualified staff, and poor record maintenance.

“Protecting the quality and safety of blood supplies is a critical priority,” said Girish Hukare, Joint Commissioner (Drugs), FDA Pune Division. “These inspections go beyond routine checks—they are vital for safeguarding patients who depend on safe blood transfusions during critical care and surgeries.”

The FDA clarified that all penal actions followed due process, allowing facilities adequate time to respond and explain their positions before final decisions were made.

This enforcement initiative is part of the FDA’s larger mission to ensure compliance and ethical standards in the healthcare and pharmaceutical sectors. Officials have pledged to continue their vigilance and warned that non-compliant establishments will face strict consequences in the months ahead.

Tags: (FDAblood banksblood storage violationsblood transfusionDrugs and Cosmetics ActGirish Hukarehealthcare compliancehealthcare safetyKolhapurlicense suspensionMaharashtra healthmedical inspectionspatient safetyPune DivisionPune newsregulatory actionSangliSataraSolapur
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