483
Seriously Clean, Ltd.FDA 483 - Seriously Clean, Ltd. - December 08, 2022
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Record Details
Seriously Clean, Ltd. in Nixa, MO, a medical device manufacturer, was cited for inadequate quality system procedures during an FDA inspection. The firm failed to adequately establish and perform design validation and design verification activities for its Wound and Skin Care products. Additionally, products were shipped to customers before final acceptance and release procedures were completed.
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ID · 5806624e-5534-4596-9251-119bee2fcf41