|
| Exchange Received Time 07/10/2017 12:37:47 Exchange Disseminated Time 07/10/2017 12:37:53 Time Taken 00:00:06 | | This is to inform you that the US FDA has issued an Establishment Inspection Report (EIR) for the Company's generic pharmaceutical manufacturing facility at Jadcherla in Telangana, India which was inspected between 24th and 28th July 2017. The inspection has now been closed by the US FDA. The Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines in response to the form 483 issued at the end of inspection. The US FDA has reviewed the CAPA and has found them acceptable. |
|
|