The US Food and Drug Administration, which inspected an Aurobindo Pharma facility in Pashamylaram in Medak District, released its report.
According to the recently unveiled FDA report, procedures designed to prevent microbiological contamination of drugs believed to be sterile have not been established or monitored in the pharmaceutical company's IV unit.
In addition, the report stated that the clothing was not worn as necessary to protect the drugs from contamination.
The inspection took place last December.
The website of Aurobindo Pharmas indicates that the unit-IV is a manufacturing facility dedicated to generic sterile injections.
Companies are encouraged to respond in writing to the FDA with their corrective action plan and then quickly implement this corrective action plan, the US agency said.