Monday, 16 September 2013

Strides Arcolab: Updates on USFDA inspections

Strides Arcolab Ltd has informed BSE that the Sterile Manufacturing Facility 2 (SFF) at Bangalore of Agila Specialties Private Limited, a wholly owned subsidiary of the Company, has received a warning letter from the United States Food and Drug Administration (US FDA).The US FDA 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.The Company is committed to work collaboratively and expeditiously with the US FDA to resolve concerns cited in the warning letter in the shortest possible time.Further, the Oncology facility at Bangalore of Agila Specialties Private Limited was also inspected recently by the US FDA and this facility has cleared the inspection with "Zero 483 status".The Company has 8 US FDA approved sterile manufacturing facilities.

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