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.
The USFDA based the letter on lapses found during an inspection at Kilitch Healthcare’s Navi Mumbai facility, which specialises in finished pharmaceutical products.
This action follows an incident where the eye drop manufacturer had to recall 27 types of eye drops sold in the United States for potential safety reasons in November last year.
Elaborating on the CGMP violations at the facility, the United States health regulator stated that the company failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, which includes the validation of all aseptic and sterilisation processes.
“Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards,” the regulator said in the letter.
The regulator highlighted that Kilitch Healthcare did not establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, and that includes validation of all aseptic and sterilisation processes.
The FDA also raised questions about the Mumbai-based firm’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.
“A current risk assessment of the potential effects of the observed failures on the quality of your drugs,” the regulator stated in the warning letter.
The USFDA has asked the pharmaceutical firm to submit a response to the warning 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 added.
First Published: Apr 11 2024 | 5:50 PM IST