Shilpa Medicare gets 4 USFDA observations for Hyderabad division
Hyderabad: After a recent inspection, the U.S. Food and Drug Administration (USFDA) has issued four observations to Shilpa Medicare's recently started Analytical Services Division situated in Hyderabad.
The inspection was conducted from 26 April 2022 to 29 April 2022.
"This is to inform you that the Company's recently started Analytical Services Division situated on first Floor of Unit 7, Nacharam, Hyderabad, Telangana was inspected by U.S. Food and Drug Administration (USFDA) during 26 Apr 2022 to 29 Apr 2022." the company said in a BSE filing.
The inspection came after Shilpa's submission of applications for four ANDA's to seek approval to use this site as alternate testing laboratory. The inspection has been closed with four observations, which are related to improvements in existing procedures and are addressable.
Read also: Shilpa Medicare clears USFDA review for Dabaspet facility
"The Company will be submitting the responses to USFDA observations within stipulated timeline and implement the corrective actions to address the observations," Shilpa Medicare further added.
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