The inspection ended with three observation under form 483
Shilpa Medicare has announced that the US FDA has completed inspection of company’s API facilities Unit-I and Unit-II located at Raichur, Karnataka.
The facility was inspected between 16th January and 19th January, 2018. The inspection has now been closed by the US FDA with three 483 observations. The company in its BSE filing stated that it is in the process of submission of corrective and preventive action (CAPA) plan to the regulator within the stiplulated timelines in the response to the form 483 issued at the end of inspection.