Rohto-Mentholatum (Vietnam) Co., Ltd. – FDA 483, Nov 1, 2019
An FDA inspection of Rohto-Mentholatum (Vietnam) Co., Ltd. revealed significant deficiencies across multiple areas of sterile drug product manufacturing. Key issues included inadequate environmental monitoring in aseptic processing, insufficient process validation, and a failure to thoroughly investigate out-of-specification results. Additionally, the firm demonstrated poor computer system controls, deficient laboratory testing procedures, and an incomplete disinfectant efficacy study, indicating a broad lack of adherence to good manufacturing practices.
ID · f877cbde-1e3a-4e3c-a9d3-cd44825d4eab
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