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

Source: https://www.keypedia.com/records/483/magellan-diagnostics-inc/91db7bc5-1928-4ba5-bd82-f3ad3a452377

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

---

## Details

- Record Type: 483
- Company Name: Magellan Diagnostics, Inc.
- Inspection Date: 2025-08-26
- Product Type: device
- Office Name: New England District Office
- Summary: Magellan Diagnostics, Inc. in North Billerica, MA, was inspected regarding its blood lead testing systems. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate corrective and preventive actions, design verification, process validation, incoming product acceptance, and risk analysis. Furthermore, the firm failed to timely report numerous medical device malfunctions and a field correction to the FDA, indicating a systemic breakdown in quality management and regulatory compliance that could impact patient safety.

## Related Documents

- [483 - 2017-06-29](https://www.keypedia.com/records/483/magellan-diagnostics-inc/1834ad81-10d1-4f74-862a-2bddde9bba15)
- [WARNING_LETTER - 2017-06-29](https://www.keypedia.com/records/warning_letter/magellan-diagnostics-inc/e84d5963-a7a4-4d35-b205-bf89391b6d3e)
- [483 - 2019-10-21](https://www.keypedia.com/records/483/magellan-diagnostics-inc/fb5b6630-e42a-432b-ba75-9e86b7ff1be2)
- [483 - 2021-06-22](https://www.keypedia.com/records/483/magellan-diagnostics-inc/c57ffd9f-7b18-4179-8e24-a55f44ac4b67)

## Related Officers

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

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

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