US FDA Issues 11 Observations For Aurobindo Pharma's US Plant

Aurobindo Pharma on Friday said the US Food and Drug Administration issued a Form 483 with 11 observations after inspecting the Raleigh plant of its wholly-owned step-down subsidiary Aurolife Pharma LLC. 

Form 483 is issued to company management at the end of an US FDA inspection to highlight any objectionable conditions observed. The inspection was conducted from March 24 to April 10, the company said in an exchange filing.

Aurobindo said the development is not expected to have any material impact on its operations and it will submit a detailed response.