US eye drop manufacturer K.C. Pharmaceuticals issued FDA warning letter citing inadequate controls to prevent microbial contamination of sterile products and ineffective quality unit Read More..

The USFDA Warning letter to K. C. Pharmaceuticals issued in August 2023, following inspection at the California facility (FEI 2026940) in Jan & Feb 2023. The Warning letter cites inadequate measures to prevent microbial contamination in aseptic lines – smoke studies are not conducted under dynamic conditions, investigations are not completed for media fill study failures occurred in 2020 and 2021, failure to perform aseptic operations in adequately controlled areas. The BMS (building management systems) to monitor and record differential pressures in aseptic facility are inadequate, operators observe and record the differential pressures from the photohelic gauges, operators has access to set the limits on photohelic gauges, frequency of monitoring pressure differentials are inadequate to detect pressure deviations which can impact aseptic conditions in filling lines. The design and operations of the ISO 5 aseptic lines do not meet the minimum standards; control of operator interventions and practices are inadequate. Cleaning validation programme for the aseptic processing line which manufacture multiple ophthalmic formulations is not completed. It did not address recovery studies and limit of detection for compounding tank and transfer lines, viscosity alone was considered a factor to identify harder to clean areas without considering other factors.

The Warning letter cites response to the inspection observations are inadequate – No detailed plan for impact assessment for product manufactured without adequate smoke studies. The response for deficiencies in cleaning and cleaning validation lacked details of how the product impact assessment will be performed, what will be evaluated and how; it also did not include a commitment for verification of cleaning to ensure cross contamination do not occur when using compounding tank, transfer lines and other equipment.

Warning letter raises concerns over the ineffective Quality unit, inadequate quality oversight over production operations. It asks the Firm to immediately and comprehensively assess its global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.

Warning letter