News | August 03, 2022
Jubilant Pharmova gets 6 observations from USFDA for its facility at Roorkee
he US FDA has issued six observations pursuant to the completion of the audit.
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.
U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi
A total of five observations for Goa and 17 for Monroe
Tirzepatide is primarily indicated for the treatment of T2D and is expected to receive its decision from the FDA in Q2 2022
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
The audit is a PAI for two of its product applications filed from this facility
Intuitive Telepresence (ITP), facilitates remote learning, and encourages interaction and collaboration between surgeons without the need to travel
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