483
WISE PLASTICS TECHNOLOGIES INCFDA 483 - WISE PLASTICS TECHNOLOGIES INC - May 19, 2023
Record Details
An FDA inspection of WISE PLASTICS TECHNOLOGIES INC in West Chicago, IL, a contract manufacturer of medical devices, revealed significant deficiencies in their quality management system. Observations included inadequate corrective and preventive action procedures, insufficient software validation for their quality system, and a quality plan that fails to reference relevant FDA regulations like 21 CFR 820. These issues indicate a lack of robust controls for managing product quality and regulatory compliance.
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ID · 6c4af411-bac1-485d-bbf8-8091fbe3df7c