# FDA 483 - Di-Chem Inc - February 13, 2020

Source: https://www.keypedia.com/records/483/di-chem-inc/64c4da9a-412d-4220-b2ab-f9ac70d18a5d

> FDA 483 for Di-Chem Inc on February 13, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Di-Chem Inc
- Inspection Date: 2020-02-13
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Di-Chem Inc, a medical device manufacturer in Champlin, MN, revealed two significant quality system deficiencies. The firm failed to conduct management reviews of its quality system for two consecutive years and allowed individuals with direct responsibility for audited matters to conduct internal quality audits.

## Related Officers

- [investigator](https://www.keypedia.com/people/yehualashet-a-gessesse/cb732900-358c-4982-a912-e98fa45142fe)

Company: https://www.keypedia.com/companies/di-chem-inc/7ccc0028-adf6-42a1-b792-4d3d8709ac64

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d