# FDA 483 - Dot International - March 05, 2020

Source: https://www.keypedia.com/records/483/dot-international/2cfb0b0e-1f3c-49b1-9553-4b21da337dd9

> FDA 483 for Dot International on March 05, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dot International
- Inspection Date: 2020-03-05
- Product Type: device
- Office Name: Chicago District Office
- Summary: Dot International, a manufacturer of Class II reusable menstrual cup devices in Evanston, IL, received a Form FDA 483 with seven observations, including repeat findings for design validation, CAPA, and complaint handling. The inspection revealed significant deficiencies in design controls, supplier management, complaint handling, and device history records, indicating a systemic lack of established and followed quality system procedures. A serious customer complaint involving illness was also not properly investigated or evaluated for MDR reportability.

## Related Documents

- [483 - 2019-02-26](https://www.keypedia.com/records/483/dot-international/3e454993-8790-41a0-b3c4-d1e248a0bf70)

## 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