The US 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) rules at its factory in Navi Mumbai.
The USFDA based the letter on errors found during an inspection at Kilitch Healthcare’s Navi Mumbai facility, which specializes in finished pharmaceutical products.
This action follows an incident in which the eye drop manufacturer had to recall 27 types of eye drops sold in the United States last November due to possible safety reasons.
Building on the CGMP violations at the facility, the U.S. health regulator stated that the company failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products claiming to be sterile, including the validation of all aseptic and sterilization processes.
“Your company has failed to ensure that laboratory data contain complete data derived from all testing necessary to ensure compliance with established specifications and standards,” the regulator said in the letter.
The regulator highlighted that Kilitch Healthcare failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of medicinal products claiming to be sterile, and which also include the validation of all aseptic and sterilization processes.
The FDA has also raised questions about the Mumbai-based company’s quality system, saying it does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness and quality of drugs manufactured there.
“A current risk assessment of the possible effects of the observed deficiencies on the quality of your medicines,” the regulator said in the warning letter.
The USFDA has asked the pharmaceutical company to submit a response to the warning letter, including a corrective action plan that the company plans to implement to correct the CGMP violations.
“After receiving this letter, you are requested to respond in writing to the office within 15 working days. Please indicate what you have done to address any discrepancies and prevent recurrence,” the letter said.
First print: April 11, 2024 | 5:50 PM IST