483
Surgitools Pty LtdSurgitools Pty Ltd – FDA 483, Apr 17, 2019
Record Details
SurgiTools (Shanghai) Medical Instruments Co., Ltd. was inspected by the FDA from April 15-17, 2019, as a medical device manufacturer. The inspection revealed a significant issue regarding the lack of adequate documentation for the cleaning process of a clean room used for packaging medical devices. This indicates a lapse in environmental control procedures.
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ID · 94638e5b-e839-4fee-8a69-ebf3f7aceed9
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