483
Wells Johnson CompanyFDA 483 - Wells Johnson Company - February 26, 2020
Record Details
An FDA inspection of Wells Johnson Company, a medical device manufacturer in Tucson, AZ, revealed significant deficiencies in their quality system. Observations included inadequate complaint investigation records, insufficient documentation of corrective and preventive actions, and infrequent management reviews of the quality system's effectiveness. These findings indicate a need for improved adherence to regulatory requirements for medical device manufacturing.
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ID · 57a4425f-a8b1-475b-8e3e-7860466053fd