Strides Arcolab’s Sterile Manufacturing Facility at Bangalore receives USFDA warning

16 Sep 2013 Evaluate

Strides Arcolab’s - Sterile Manufacturing Facility 2 (SFF) at Bangalore of Agila Specialties, a wholly owned subsidiary of the company, has received a warning letter from the United States Food and Drug Administration (USFDA). The USFDA inspected SFF in the month of June 2013 and the inspection resulted in issuance of Form FDA 483 with observations. The company responded to the 483 observations by implementing corrective actions.

Besides, the company is committed to work collaboratively and expeditiously with the USFDA to resolve concerns cited in the warning letter in the shortest possible time.

Further, the Oncology facility at Bangalore of Agila Specialties was also inspected recently by the USFDA and this facility has cleared the inspection with ‘Zero 483 status’. The company has 8 USFDA approved sterile manufacturing facilities.

Strides Arcolab is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures wide range of IP-lead niche pharmaceutical products with an emphasis on sterile injectables.

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