# FDA 483 - Dot International - February 26, 2019

Source: https://www.keypedia.com/records/483/dot-international/3e454993-8790-41a0-b3c4-d1e248a0bf70

> FDA 483 for Dot International on February 26, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dot International
- Inspection Date: 2019-02-26
- Product Type: device
- Office Name: Chicago District Office
- Summary: Dot International, a manufacturer and repackager/relabeler in Evanston, IL, was cited with nine observations during an FDA inspection. The firm failed to establish and maintain numerous critical quality system procedures, including design controls, product quality definition, supplier evaluation, incoming product acceptance, device master and history records, corrective and preventive actions, and complaint handling. Additionally, the firm lacked written Medical Device Reporting (MDR) procedures and did not assess complaints for MDR reportability.

## Related Documents

- [483 - 2020-03-05](https://www.keypedia.com/records/483/dot-international/2cfb0b0e-1f3c-49b1-9553-4b21da337dd9)

## Related Officers

- [Recall Coordinator](https://www.keypedia.com/people/emma-schaefer/10299982-dce6-4fea-a3e9-8167030b0331)

Company: https://www.keypedia.com/companies/dot-international/ac254f69-6339-474a-8998-b473349a2d3e

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669