Drug Approval | March 13, 2023
Shilpa Medicare gets 2 minor observations from USFDA for Unit VII, Analytical Services Division
The company will be submitting the responses to US FDA observations within stipulated timeline
The company will be submitting the responses to US FDA observations within stipulated timeline
The company had responded to the agency and carried out the required corrective actions.
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
There are no data integrity (DI) observations.
he US FDA has issued six observations pursuant to the completion of the audit.
The company has responded to the warning letter and carried out the committed corrections.
A total of five observations for Goa and 17 for Monroe
The unit is an oral manufacturing facility at Jedcherla, Hyderabad
The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days
The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory
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