Strides Pharma Science arm New York facility gets 4 USFDA observations

At the conclusion of the inspection, the U.S. FDA has issued a Form 483 with four observations. These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

"SPI will respond to these observations comprehensively to FDA within the stipulated time and is confident of addressing all the observations to the satisfaction of USFDA," the company stated in a BSE filing.  

Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donor- funded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Italy (Milan), Kenya (Nairobi), and the United States (New York). The Company focuses on “difficult to manufacture” products sold in over 100 countries.