FDA 483 - Lake Chemicals Private Limited - August 05, 2019

An FDA inspection of Lake Chemicals Pvt. Ltd. in Bangalore, India, revealed significant deficiencies in laboratory controls and facility maintenance for Active Pharmaceutical Ingredients (APIs). Issues included uncontrolled and incomplete laboratory records, lack of complete data, and poor building maintenance with water leaks and unlabeled equipment. These findings indicate a serious lack of adherence to good manufacturing practices.