Magellan Diagnostics, Inc.
FDA inspection history across 2 sites, 2017 to 2025
- 2
- Warning letters
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Warning letter
- Close-out
- Form 483
2017: one warning letter and one Form 483; 2019: one Form 483; 2021: one close-out letter; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–21Two Form 483s, one warning letter and one close-out letter, at North Billerica, Massachusetts and Cincinnati, Ohio.
- 2017The longest 483 on file: 9 observations over 11 pages at North Billerica, Massachusetts.
- 2025One warning letter, at Cincinnati, Ohio.
Cited most
Across all Magellan Diagnostics observations on file
- 21 CFR 820.30(g)Design controls5
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 806.10(b)Reports of corrections and removals1
The complete Magellan Diagnostics file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Cincinnati, Ohio
One warning letter and one close-out letter · 2021 to 2025
Latest: Warning letter, Dec 22, 2025 →North Billerica, Massachusetts
Two Form 483s · 2017 to 2019 · 14 observations
Latest: Form 483, Oct 21, 2019 →
Also: one document not tied to a site.
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-12-22 | Warning letter Warning letter | Cincinnati, Ohio | — | $99 |
| 2021-08-03 | Close-out Close-out letter | Cincinnati, Ohio | — | $99 |
| 2019-10-21 | 483 Form 483 | North Billerica, Massachusetts | 5 | $99 |
| 2017-10-23 | Warning letter Warning letter | — | — | $99 |
| 2017-06-29 | 483 Form 483 | North Billerica, Massachusetts | 9 | $99 |
Investigators on these documents
FEI number 1218996 · most recent document Dec 22, 2025
About Magellan Diagnostics, Inc.
How many FDA Form 483s has Magellan Diagnostics, Inc. received?
FDA Intel has 2 Form 483s on file for Magellan Diagnostics, Inc.; the most recent is dated Oct 21, 2019.
When was Magellan Diagnostics, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Magellan Diagnostics, Inc. is a Form 483 dated Oct 21, 2019, for the site in North Billerica, Massachusetts.
What did FDA cite at Magellan Diagnostics, Inc.?
The regulations cited most in the observations on file for Magellan Diagnostics, Inc. are 21 CFR 820.30(g) (Design controls), 5 times; 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 2 times.
Has Magellan Diagnostics, Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Magellan Diagnostics, Inc.; the most recent is dated Dec 22, 2025.