The USFDA's warning letter to Kilitch Healthcare India was a result of CGMP violations found at the company's Navi Mumbai plant, which specializes in producing finished pharmaceutical products. The regulatory body highlighted deficiencies in the establishment and implementation of written procedures aimed at preventing microbiological contamination in drug products, specifically those claiming to be sterile. Additionally, the FDA pointed out that the company's quality system failed to ensure accurate and integral data to support the safety, effectiveness, and quality of the drugs manufactured at the facility.
In response to the identified issues, the USFDA directed Kilitch Healthcare to submit a detailed response to the warning letter, which should include a corrective action plan outlining how the company intends to address and rectify the CGMP violations. The FDA emphasized the importance of specifying the actions taken to address deviations and prevent their recurrence within 15 working days of receiving the letter. Specifically, the regulatory body expressed concerns regarding the potential impact of the observed failures on the quality of the drugs being produced at the Navi Mumbai plant.