US inspectors cite serious quality issues at Aurobindo Pharma's Unit 4

The US Food and Drug Administration(USFDA) has issued Form 483 with 9 observations to Aurobindo Pharma Limited's unit 4 in Hyderabad, citing serious deficiencies in maintaining the manufacturing quality standards. The FDA representatives had inspected the facility between February 12-20, 2018.

Located in Pashamailaram industrial estate on the city outskirts, Unit-4 is a dedicated manufacturing facility for generic sterile injectables ( lyophilized and powder injections, prefilled syringes), opthalmics and low volume parenterals.

According to the Form 483, a copy of which was reviewed by this reporter, the inspection team has noticed poor maintenance of equipment and premises among other quality issues at