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 in its Navi Mumbai plant.
The USFDA based the letter on the lapses that were found during an inspection in Kilitch Healthcare’s Navi Mumbai facility, which specializes in finished pharmaceutical products.
The US health regulator stated that the company failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.
The FDA also raised questions on Kilitch Healthcare’s quality system, stating that it does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured there.
USFDA has asked Kilitch Healthcare to submit a response to the letter, including a corrective action plan that the firm plans to enact to rectify the CGMP violations.
“After you receive this letter, you are directed to respond to the office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence,” the letter said.