FDA 483 - Alkem Laboratories Limited - February 21, 2020

Alkem Laboratories Limited, a drug manufacturer in Baddi, India, received an FDA Form 483 citing two observations related to quality control and equipment validation. The firm failed to perform a Performance Qualification for equipment used in drug product inspection and did not conduct an Out-of-Specification investigation for a Total Organic Carbon system failure. These deficiencies indicate a need for improved adherence to manufacturing and quality system regulations.