FDA 483 - Qapel Medical Inc. - August 08, 2024

An FDA inspection of Qapel Medical Inc. in Fremont, CA, a medical device manufacturer, revealed significant deficiencies across multiple quality system areas related to their Hippo 072 Aspiration System. The firm failed to adequately document design inputs, establish verifiable design verification procedures, properly manage design changes, and control promotional materials. Additionally, issues were noted in supplier management, complaint handling, and employee training, indicating a broad lack of adherence to established quality system requirements.