# FDA 483 - SDI Diagnostics, Inc. - September 30, 2021

Source: https://www.keypedia.com/records/483/sdi-diagnostics-inc/5113c276-cc7e-4643-aa38-ec6fdce5feca

> FDA 483 for SDI Diagnostics, Inc. on September 30, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SDI Diagnostics, Inc.
- Inspection Date: 2021-09-30
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: SDI Diagnostics, Inc. in South Easton, MA, was inspected regarding its manufacturing operations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for acceptance activities, equipment calibration, corrective and preventive actions, complaint handling, and supplier controls. These observations indicate a need for comprehensive improvements in the firm's quality management system.

## Related Officers

- [company_representative](https://www.keypedia.com/people/david-j-sullivan/63b78401-cec1-4b9f-8617-256ad34551f5)
- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/sdi-diagnostics-inc/7a3d0831-9376-4545-a7b1-d3655d2fe217

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94