# FDA 483 - Netdirect Distribution, LLC - October 28, 2019

Source: https://www.keypedia.com/records/483/netdirect-distribution-llc/f8a81668-ffd2-413c-a1c7-e49fd8ea95b2

> FDA 483 for Netdirect Distribution, LLC on October 28, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Netdirect Distribution, LLC
- Inspection Date: 2019-10-28
- Product Type: other
- Office Name: Denver District Office
- Summary: Netdirect Distribution, LLC, an initial importer/distributor in Denver, CO, was cited for significant deficiencies in its quality system. The inspection revealed a complete lack of written procedures for managing complaints, corrective and preventive actions (CAPA), and Medical Device Reporting (MDR). These observations indicate fundamental gaps in the firm's operational controls.

## Related Officers

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

Company: https://www.keypedia.com/companies/netdirect-distribution-llc/beb38377-d52c-49c4-b5d0-b68561315e4e

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