FDA 483 - Algomedica, Inc. - August 22, 2019

An FDA inspection of Alqemedica, Inc., a medical device manufacturer in Sunnyvale, CA, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for corrective and preventive actions, design reviews, and management reviews. Additionally, issues were noted with documenting device installations and maintaining proper document control, indicating a broad lack of adherence to quality system regulations.