# FDA 483 - Medicol USA Inc. - September 12, 2019

Source: https://www.keypedia.com/records/483/medicol-usa-inc/21bcfaf8-46eb-4c05-9b74-e9b378c95cc3

> FDA 483 for Medicol USA Inc. on September 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medicol USA Inc.
- Inspection Date: 2019-09-12
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Medicol USA Incorporated, a medical device manufacturer in Los Gatos, CA, was inspected by the FDA from September 10-12, 2019. The inspection revealed significant deficiencies in the firm's quality system, including a lack of established procedures for quality policy, CAPA, non-conforming product, management review, and the absence of quality audits and documented management review results. These observations indicate a fundamental breakdown in the firm's quality management system.

## Related Officers

- [investigator](https://www.keypedia.com/people/eric-j-heinze/f16828ab-f1e0-4556-bccc-700d93965b86)
- [Investigator](https://www.keypedia.com/people/james-a-lane/f6cd3d8d-7de9-45c5-9380-7e0c5de4720e)

Company: https://www.keypedia.com/companies/medicol-usa-inc/133f090f-8273-4385-a6fe-ddfe727d30f7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b