Aurobindo Pharma facility manufacturing Sterile Injections fails to establish sterility, says USFDA
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 Aurobindo Pharma.
Hyderabad: In a major setback, city-based Aurobindo Pharma has fallen under the US Food and Drug Administration (USFDA) radar. The USFDA which conducted an inspection of the company's unit-IV facility at Pashamylaram in Medak district has formed its report wherein the agency states that the company is unable to prevent microbiological contamination of drugs claiming to be bacteria free.
The drug company's website says unit-IV is a dedicated manufacturing facility for generic sterile injections.
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.
Companies are encouraged to respond to the FDA in writing with their corrective action plan and then implement that corrective action plan expeditiously, the US agency says.
The plant is vital to Aurobindo's U.S. business. According to a Fierce Pharma, it has many pending drug applications before the FDA, and the company has expected it will generate about Rs 25 crore in sales from that facility by the end of 2020.
Medical dialogues had earlier reported that the US health regulator had issued 9 observations after inspection of its unit 4 formulation facility in Hyderabad and issued form 483. As per the USFDA, form 483 notified a company’s management of objectionable conditions at its facility which included issues over equipment cleaning. That report also noted signs of “vermin,” including rodents and insects, in the building used for manufacturing, packaging and storage.
In March 2018, the US Food and Drug Administration officials found a ‘large female mosquito’ in a facility of Aurobindo Pharma during the inspection, which, according to them, was not ‘free of infestation by rodents and other insects’.
The company has reportedly had similar problems at another sterile manufacturing plant in nearby Bachupally. It was cited with 6 observations in 2017.