# FDA 483 - Bio-Mechanical Composites, Inc. - August 09, 2019

Source: https://www.keypedia.com/records/483/bio-mechanical-composites-inc/06635b49-0ea4-4d85-b5fc-a04ded58d46f

> FDA 483 for Bio-Mechanical Composites, Inc. on August 09, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio-Mechanical Composites, Inc.
- Inspection Date: 2019-08-09
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Bio-Mechanical Composites, Inc. in Des Moines, IA, revealed significant deficiencies in their quality system. The firm failed to establish procedures for corrective and preventive actions (CAPA), medical device reporting (MDR), and the receiving, reviewing, and evaluating of complaints. These fundamental omissions indicate a lack of a robust quality management system for medical device manufacturing.

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.keypedia.com/companies/bio-mechanical-composites-inc/cb7c155e-8575-4d87-8abd-f9e3f97380f4

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