USFDA issues 'warning letter' to Kilitch Healthcare over GMP violation

The FDA questioned Kilitch's quality system, citing concerns about its ability to ensure data accuracy and integrity for drug safety

The United States Food and Drug Administration (USFDA) has issued a ‘warning letter’ to Mumbai-based pharma 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 specialises in finished pharmaceutical products.

This comes after the eyedrop manufacturer had to recall 27 types of eyedrops it sold in the United States for potential safety reasons, in November last year.  

Elaborating on the CGMP violations at the facility, 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 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 its warning letter.

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. “A current risk assessment of the potential effects of the observed failures on the quality of your drugs”, the drug regulator said. 

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.

FINDINGS
 

>Firm fails to establish proper contamination prevention procedures
 

>Laboratory records lacked complete data for compliance verification

>FDA directs firm to submit timely corrective action plan

“Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile…” - Center for Drug Evaluation and Research, USFDA