# FDA 483 - Magellan Diagnostics, Inc. - June 22, 2021

Source: https://www.keypedia.com/records/483/magellan-diagnostics-inc/c57ffd9f-7b18-4179-8e24-a55f44ac4b67

> FDA 483 for Magellan Diagnostics, Inc. on June 22, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Magellan Diagnostics, Inc.
- Inspection Date: 2021-06-22
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Magellan Diagnostics, Inc. in North Billerica, MA was inspected by the FDA from June 2-22, 2021, and received one observation. The inspection revealed inadequate validation of a process used in the production of LeadCare blood lead test kits. This deficiency led to the distribution of unvalidated test kits, some of which were subsequently recalled.

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## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/magellan-diagnostics-inc/cb8c497d-025f-4929-a799-724a015d3677

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