483
Austco Marketing & Service LTD.FDA 483 - Austco Marketing & Service LTD. - September 23, 2022
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Record Details
An FDA inspection of Austco Marketing & Service LTD., a medical device manufacturer in Irving, TX, from September 19-23, 2022, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for complaint handling, internal audits, supplier control, and corrective and preventive actions. These issues indicate a systemic breakdown in maintaining a compliant quality management system.
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ID · 30a3b6bb-6147-4c91-9d6d-630a525f6e23