# FDA 483 - D. O. Weaver and Company - May 12, 2023

Source: https://www.globalkeysolutions.net/records/483/d-o-weaver-and-company/83617aac-0c90-4f3b-a970-83637b1b57f1

> FDA 483 for D. O. Weaver and Company on May 12, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: D. O. Weaver and Company
- Inspection Date: 2023-05-12
- Product Type: device
- Office Name: Denver District Office
- Summary: D. O. Weaver and Company, a medical device manufacturer in Aurora, CO, received a Form FDA 483 with two significant observations. The firm failed to adequately validate processes for its Nuprep® and Ten20® products, specifically regarding the range of process parameters and statistical rationale for sample sizes. Additionally, the company's investigation records for MDR reportable complaints were found to be deficient, with insufficient follow-up attempts and a failure to report an adverse event.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.globalkeysolutions.net/companies/d-o-weaver-and-company/9d3abd0b-5acb-4fea-800f-ff8cb0a9daeb

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face