Shilpa Medicare's Analytical Services Division situated at Unit 7, Nacharam, Hyderabad, Telangana has been inspected by US FDA from March 8 to March 10, 2023. This is a full GMP inspection.

The inspection is closed with two minor observations, which are related to improvements in existing procedures and are addressable.

The company will be submitting the responses to US FDA observations within the stipulated timeline and will work towards implementing the corrective actions to address the observations.

This is the second US FDA inspection on the site. The initial inspection was done in Apr 2022, for which the GMP clearance (EIR) was issued in July 2022.

The facility is involved in the analytical testing of drug products, drug substances, raw materials & packing materials. It is also engaged in analytical method validations, method transfers and the conduct of other miscellaneous studies. This facility is involved in the testing of US/EU & other markets commercial batches.