FDA 483 - Product Design and Development Corp. - March 17, 2022

An FDA inspection of Product Design and Development Corp. in Ellisville, MO, revealed significant deficiencies in their quality system, with six observations noted. These observations highlight a lack of established procedures for critical areas such as corrective actions, complaint handling, medical device reporting, quality planning, device history records, and employee training. Many of these issues were repeat observations from previous inspections, indicating persistent non-compliance.