483
Parks Medical Electronics, IncFDA 483 - Parks Medical Electronics, Inc - June 15, 2023
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Record Details
Parks Medical Electronics, Inc. in Aloha, OR, was inspected regarding its manufacturing of Class 2 medical devices, specifically ultrasound probes. The inspection revealed significant deficiencies in process validation, equipment calibration and maintenance, and corrective and preventive action procedures. These issues indicate a lack of adherence to established quality system requirements.
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ID · f653a6eb-ec13-4579-b3b3-93ac8bafe942