USFDA Issues Warning Letter to Kilitch Healthcare India for CGMP Violations
The United States Food and Drug Administration (USFDA) has issued a warning letter to Mumbai-based pharmaceutical company Kilitch Healthcare India for violating central good manufacturing practices (CGMP) regulations at its Navi Mumbai plant.
Failure to establish and follow procedures to prevent microbiological contamination of sterile drug products. This includes inadequate validation of aseptic and sterilization processes.
Incomplete laboratory records. The company failed to ensure that laboratory records included complete data necessary to guarantee compliance with established specifications and standards.
Inadequate quality system. The USFDA found that Kilitch Healthcare's quality system does not adequately ensure the accuracy and integrity of data supporting the safety, effectiveness, and quality of the drugs manufactured at the facility.
The USFDA has requested a response from Kilitch Healthcare within 15 working days, outlining a corrective action plan to address the identified CGMP violations and prevent their recurrence.
This warning letter follows a November 2023 recall of 27 types of eyedrops sold by Kilitch Healthcare in the United States due to potential safety concerns.