Lacunae in Aurobindo Pharma's Medak facility in Andhra, says FDA report

The US Food and Drug Administration, which conducted an inspection of a facility of Aurobindo Pharma at Pashamylaram in Medak district, has released its report.

According to the FDA report unveiled recently, procedures designed to prevent microbiological contamination of drug products purporting to be sterile have not been established and followed in the unit-IV of the drug company.

Besides, the report said preparative apparel was not worn as necessary to protect drug products from contamination.

The inspection was conducted in December last.

Aurobindo Pharmas website says unit-IV is a dedicated manufacturing facility for generic sterile injections.

Companies are encouraged to respond to the FDA in writing with their corrective actionplan and then implement that corrective actionplan expeditiously, the US agency says.