Shilpa Medicare has received three 483 observations from the United States Food & Drug Administration (USFDA) for its API facility located at Raichur. The USFDA has completed inspection of company’s API facilities Unit-I and Unit-II located at Raichur, Karnataka, India which was inspected between January 16 and January 19, 2018.
The inspection has now been closed by the USFDA with three 483 observations. The company is in the process of submission of 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.
Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.
