FDA 483 - Pedicraft, Inc. - January 17, 2020

Pedicraft, Inc., a medical device manufacturer in Jacksonville, FL, was inspected by the FDA, revealing significant deficiencies in its quality system. The inspection found that risk analysis for Class II bassinets and cribs was incomplete and did not cover all foreseeable risks. Additionally, the firm's procedures for corrective and preventive actions and quality audits were deemed inadequately established.