483
TacPro LLCTacPro LLC – FDA 483, Feb 28, 2020
Record Details
An FDA inspection of Creanna Medical Inc. in Plymouth, MN, revealed significant deficiencies across its quality management system. The firm failed to adequately establish procedures for corrective and preventive actions, complaint handling, process validation, and control of non-conforming products. These issues indicate a systemic breakdown in maintaining a robust quality system.
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ID · d2bc046a-37f9-4c0f-b7e2-d4abea69e84b
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