483
BioSculptor CorporationBioSculptor Corporation – FDA 483, Oct 19, 2022
Record Details
An FDA inspection of BioSculptor Corporation in Hialeah, FL, a medical device manufacturer of the kinderBAND™ cranial orthosis helmet, revealed significant deficiencies in their quality system. The inspection cited repeat observations regarding inadequate equipment calibration procedures and untrained personnel conducting quality audits. Additional issues included failures to maintain device history records and establish adequate supplier management processes.
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ID · b3c36059-2dd7-4e11-b9bb-7f76d9d8446d
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