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 ...
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