483
Apnea Sciences CorporationApnea Sciences Corporation – FDA 483, Aug 19, 2021
Record Details
Apnea Sciences Corporation, a medical device manufacturer in Aliso Viejo, CA, was inspected by the FDA from August 16-19, 2021. The inspection revealed significant deficiencies in their quality system, specifically regarding corrective and preventive actions, device history records, and acceptance activities documentation. These issues indicate a lack of adherence to established procedures and regulatory requirements for medical device manufacturing.
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ID · 1a1c176a-f651-429c-9b73-6f7420db3772
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