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US FDA issues several observations at Baxter's Indian facilities

The U.S. Food and Drug Administration recorded a number of violations at Claris Lifesciences Ltd's facilities in Ahmedabad, India, which are now owned by Baxter International Inc.

The U.S. FDA began the inspection in late July, immediately before Baxter acquired Claris' generic injectables unit.

The regulator completed its inspection Aug. 4.

Baxter said it would respond to the observations and implement corrective and preventive actions to address the regulator's concerns.