# FDA 483 - Magellan Diagnostics, Inc. - August 26, 2025

Source: https://www.globalkeysolutions.net/records/483/magellan-diagnostics-inc/2dbc215c-37c2-409e-bb0a-3c6b10971223

> FDA 483 for Magellan Diagnostics, Inc. on August 26, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Magellan Diagnostics, Inc.
- Inspection Date: 2025-08-26
- Product Type: device
- Office Name: New England District Office

## Related Documents

- [483 - 2017-06-29](https://www.globalkeysolutions.net/records/483/magellan-diagnostics-inc/1834ad81-10d1-4f74-862a-2bddde9bba15)
- [483 - 2025-08-26](https://www.globalkeysolutions.net/records/483/magellan-diagnostics-inc/a4161924-02eb-4144-aaa9-6952faf68824)
- [WARNING_LETTER - 2017-06-29](https://www.globalkeysolutions.net/records/warning_letter/magellan-diagnostics-inc/e84d5963-a7a4-4d35-b205-bf89391b6d3e)
- [483 - 2019-10-21](https://www.globalkeysolutions.net/records/483/magellan-diagnostics-inc/0d9be2ec-0735-421f-bf8d-9bc4635a713d)
- [483 - 2025-08-26](https://www.globalkeysolutions.net/records/483/magellan-diagnostics-inc/91db7bc5-1928-4ba5-bd82-f3ad3a452377)

## Related Officers

- [Sunita Pandey](https://www.globalkeysolutions.net/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

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

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144