Sterile Manufacturing Deviations Found at Japan Facility

February 16, 2017

FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.

On Feb. 2, 2017, FDA issued a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found current good manufacturing practices (CGMP) violations at the company’s Tokyo facility. Violations found during the inspection, which took place from Feb. 8–12, 2016, included inadequate environmental monitoring systems and insufficient written procedures for the prevention of microbiological contamination.

According to the warning letter, the company failed to perform routine personnel monitoring during sterile manufacturing. FDA stated, “[your new standard operating procedure] does not sufficiently address the appropriate response to take when personnel monitoring yields results outside of action and alert limits. In addition, it is unclear if the action and alert limits are supported by an appropriate scientific rationale.”

The company also failed to perform routine surface sampling of cleanroom environments. The agency requested the company justify sampling locations and associated action and alert limits, ensure all locations are sampled at appropriate frequencies, and define circumstances for investigations of and responses to out-of-limit results.

FDA also questioned the company’s restricted access barrier system (RABS), saying the company had failed to perform smoke studies “to demonstrate unidirectional airflow over the exposed sterile product during processing.” FDA stated in the letter, “Your firm has since renovated your RABS to use a closed design and conducted validation studies. However, your response is deficient in that it does not address your release of (b)(4) products currently on the US market using the original open RABS design.” The agency asked the company to provide a risk assessment describing process failure modes, a sterility history, and actions taken to evaluate the acceptability of product manufactured on the open RABS.

Source: FDA