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

Source: https://www.keypedia.com/records/483/product-design-and-development-corp/ef1bd49d-a601-4d00-8f6e-3b0c8be37e42

> FDA 483 for Product Design and Development Corp. on March 17, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Product Design and Development Corp.
- Inspection Date: 2022-03-17
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.

## Related Documents

- [483 - 2025-01-24](https://www.keypedia.com/records/483/product-design-and-development-corp/91276afc-e93f-4bde-8f47-844795054c95)

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/product-design-and-development-corp/7159aa80-c032-42e7-a2f8-4e907c4bfe0c

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8