483
ITI Manufacturing, Inc.ITI Manufacturing, Inc. – FDA 483, Oct 28, 2022
Record Details
ITI Manufacturing, Inc., an initial importer and contract manufacturer in Sugar Land, TX, was inspected by the FDA from October 18-28, 2022. The inspection revealed significant deficiencies in the firm's quality management system, specifically regarding inadequate procedures for corrective and preventive actions and product handling. These issues indicate a lack of established and complete procedures essential for device quality.
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ID · ed5c1750-4abc-4f40-8d3d-a39c09f0363f
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