# Magellan Diagnostics, Inc., North Billerica, MA – FDA Inspections

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

> Inspection records and compliance data for Magellan Diagnostics, Inc. in North Billerica, Massachusetts. 7 FDA inspections on record (2 OAI), 2 Form 483s, 1 warning letter, last inspected August 26, 2025.

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## Details

- Name: Magellan Diagnostics, Inc.
- FEI Number: 1218996
- Facility Type: Manufacturer
- Address Line 1: 101 Billerica Ave Bldg 4
- City: North Billerica
- State: Massachusetts
- Zip Code: 01862
- Country Name: United States
- Address: 101 Billerica Ave Bldg 4, North Billerica, Massachusetts 01862, United States
- Country: United States

## Related Documents

- [483 - Magellan Diagnostics, Inc. - 2025-08-26](https://www.keypedia.com/records/483/magellan-diagnostics-inc/91db7bc5-1928-4ba5-bd82-f3ad3a452377) — source: FDA, date: August 26, 2025
- FDA Inspection 1280392 - Magellan Diagnostics, Inc. - 2025-08-26 — classification: Official Action Indicated (OAI), source: FDA, date: August 26, 2025
- [FDA Inspection 1280392 - Magellan Diagnostics, Inc. - 2025-08-26](https://www.keypedia.com/records/fda_inspections/magellan-diagnostics-inc/fd15f720-9b1c-4475-bbe3-cf2f14911055) — classification: Official Action Indicated (OAI), source: FDA, date: August 26, 2025
- FDA Inspection 1280392 - Magellan Diagnostics, Inc. - 2025-08-26 — classification: Official Action Indicated (OAI), source: FDA, date: August 26, 2025
- FDA Inspection 1280392 - Magellan Diagnostics, Inc. - 2025-08-26 — classification: Official Action Indicated (OAI), source: FDA, date: August 26, 2025
- [483 - Magellan Diagnostics, Inc. - 2021-06-22](https://www.keypedia.com/records/483/magellan-diagnostics-inc/c57ffd9f-7b18-4179-8e24-a55f44ac4b67) — source: FDA, date: June 22, 2021
- [FDA Inspection 1144696 - Magellan Diagnostics, Inc. - 2021-06-22](https://www.keypedia.com/records/fda_inspections/magellan-diagnostics-inc/7cc14c22-8447-401c-a00a-ad646a238767) — classification: Voluntary Action Indicated (VAI), source: FDA, date: June 22, 2021
- [483 - Magellan Diagnostics, Inc. - 2019-10-21](https://www.keypedia.com/records/483/magellan-diagnostics-inc/fb5b6630-e42a-432b-ba75-9e86b7ff1be2) — source: FDA, date: October 21, 2019
- [FDA Inspection 1107302 - Magellan Diagnostics, Inc. - 2019-10-21](https://www.keypedia.com/records/fda_inspections/magellan-diagnostics-inc/532221bd-aa9e-456f-a0a8-c7068abb890a) — classification: Voluntary Action Indicated (VAI), source: FDA, date: October 21, 2019
- FDA Inspection 1107302 - Magellan Diagnostics, Inc. - 2019-10-21 — classification: Voluntary Action Indicated (VAI), source: FDA, date: October 21, 2019
- [483 - Magellan Diagnostics, Inc. - 2017-06-29](https://www.keypedia.com/records/483/magellan-diagnostics-inc/1834ad81-10d1-4f74-862a-2bddde9bba15) — source: FDA, date: June 29, 2017
- [WARNING_LETTER - Magellan Diagnostics, Inc. - 2017-06-29](https://www.keypedia.com/records/warning_letter/magellan-diagnostics-inc/e84d5963-a7a4-4d35-b205-bf89391b6d3e) — source: FDA, date: June 29, 2017
- FDA Inspection 1016218 - Magellan Diagnostics, Inc. - 2017-06-29 — classification: Official Action Indicated (OAI), source: FDA, date: June 29, 2017
- [FDA Inspection 1016218 - Magellan Diagnostics, Inc. - 2017-06-29](https://www.keypedia.com/records/fda_inspections/magellan-diagnostics-inc/44e3aa66-7345-498c-9f71-5586ff14a628) — classification: Official Action Indicated (OAI), source: FDA, date: June 29, 2017
- FDA Inspection 884803 - Magellan Diagnostics, Inc. - 2014-06-25 — classification: No Action Indicated (NAI), source: FDA, date: June 25, 2014

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## Related Officers

- [Business Owner](https://www.keypedia.com/people/james-whitney/072bf37e-a5c6-41bb-b0c1-1f944b112b43)
- [Consumer Safety Officer](https://www.keypedia.com/people/suzanne-m-healy/a4159f42-8968-4dec-89e3-46a5412bc47a)
- [Amy M. Winslow](https://www.keypedia.com/people/amy-m-winslow/4778bf3a-1f98-48a1-96dc-10382bd4c798)
- [John A. Krautler](https://www.keypedia.com/people/john-a-krautler/9e25d71a-5a81-4603-8445-615bea77fd4a)
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