Shilpa Medicare Analytical Services Division gets 2 minor observations from USFDA
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Karnataka: Shilpa Medicare has announced that the US Food and Drug Administration (USFDA) has closed the inspection with two minor observations at the company's Analytical Services Division situated at Unit 7, Nacharam, Hyderabad, Telangana. This is a full GMP inspection.
The unit has been inspected by US FDA from 08 March 2023 to 10 March 2023.
"The Company will be submitting the responses to US FDA observations within stipulated timeline and will work towards implementing the corrective actions to address the observations," Shilpa medicare stated in a recent BSE filing.
"The inspection is closed with 2 minor observations, which are related to improvements in existing procedures and are addressable," the company added.
This is the second US FDA inspection on the site.
The initial inspection was done during April 2022, for which the GMP clearance (EIR) was issued in July 2022.
The facility is involved in analytical testing of drug products, drug substances, raw materials & packing materials. It is also engaged in analytical method validations, method transfers and conduct of other miscellaneous studies. This facility is involved in the testing of US/EU & other markets commercial batches.
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