USFDA finds several violations in Aurobindo sterile injections unit
The US Food and Drug Administration has observed several violations and shortcomings in Aurobindo Pharma’s sterile injections facility in Pashamylaram, Hyderabad, in yet another setback for the firm.
FDA investigators have observed violations in sterilisation process to prevent microbial contamination and shortcomings in facility management procedures along with lapses in the design of the manufacturing plant. The same unit had come under the FDA radar in March 2018.
The inspection at Unit IV from November 4-13 found “procedures designed to prevent microbial contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilisation process,” said the Form 483 ‘inspectional observation’ report. EThas seen a copy of the Form 483 issued to Aurobindo Pharma.