# FDA 483 - Magellan Diagnostics, Inc. - October 21, 2019

Source: https://www.keypedia.com/records/483/magellan-diagnostics-inc/fb5b6630-e42a-432b-ba75-9e86b7ff1be2

> FDA 483 for Magellan Diagnostics, Inc. on October 21, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Magellan Diagnostics, Inc.
- Inspection Date: 2019-10-21
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Magellan Diagnostics, Inc. in North Billerica, MA, revealed five significant observations, many of which were repeat findings. The firm demonstrated inadequate procedures for corrective and preventive actions, complaint handling, and medical device reporting. Additionally, deficiencies were noted in risk analysis and the maintenance of device master records for their LeadCare product line.

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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