483
Lone Star Medical Products, Inc.Lone Star Medical Products, Inc. – FDA 483, Apr 27, 2023
Record Details
Lone Star Medical Products, Inc. in Stafford, TX, was inspected and cited for significant deficiencies across its quality system. The inspection revealed issues with complaint investigations, software validation, design transfer, corrective and preventive actions, and incoming product acceptance. These findings indicate a systemic breakdown in ensuring product quality and compliance with established procedures.
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ID · 376fd581-f97d-4100-ba84-6d82a6d88880
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