|
| Exchange Received Time 04/12/2018 14:09:21 Exchange Disseminated Time 04/12/2018 14:09:29 Time Taken 00:00:08 | In furtherance to the intimation captioned "US FDA Inspection at Alkem's manufacturing facility located at St. Louis, USA" dated 28th March, 2018, this is to inform you that US FDA has issued an Establishment Inspection Report (EIR) for the Company's manufacturing facility located at St. Louis, USA which was inspected from 12th March, 2018 to 16th March, 2018.
In response to the Form 483 issued by the US FDA containing one observation, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The inspection has now been closed by the US FDA.
Kindly take the same on record. |
|
|