483
Caragh PrecisionFDA 483 - Caragh Precision - July 17, 2025
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Record Details
Caragh Precision, a medical device manufacturer in Galway, Ireland, received a Form FDA-483 with three observations during an inspection. The inspection revealed deficiencies in the firm's supplier assessment, change control, and corrective and preventive action procedures. These issues indicate a need for improved quality system controls to ensure product quality and compliance.
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ID · c1393389-5138-46e6-ba1d-a5aaeb0f78e0