Cadila Healthcare Ltd. settled concerns raised by the U.S. Food and Drug Administration following an inspection of the company's Baddi facility in India.
The company received a report from the FDA regarding the successful closure of inspection points, or 483s, raised by the regulatory body following the inspection of the facility between Feb. 21 and March 1, the company said in a news release.
The FDA previously issued three observation points regarding the facility, including concerns with the design of the facility's equipment, inadequate production and control records and incomplete information in batch production and control records.