Magellan Diagnostics, Inc.
Form 483 issued October 21, 2019 · North Billerica, Massachusetts
- Inspection
- Oct 1 – Oct 21, 2019
- Investigator
- Sara M. Onyango
- Observations
- 5
- Pages
- 7
- FEI number
- 1218996
In short: On October 21, 2019, FDA issued a Form 483 with 5 observations to Magellan Diagnostics, Inc. in North Billerica, Massachusetts (FEI 1218996) after an inspection that ran Oct 1 – Oct 21, 2019. The investigator was Sara M. Onyango. Most observations concern cAPA and design controls.
At a glance
3 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have not been adequately established. A. Corrective actions to remove…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not…
- 03
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 04
Risk analysis is…
This inspection in context
Sara M. Onyango
9 documents · 2019–2026
Cites 820.30(f) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmMagellan Diagnostics, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Magellan Diagnostics, Inc.?
FDA listed 5 observations on this Form 483, mostly about cAPA, design controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Magellan Diagnostics, Inc.?
Sara M. Onyango is named on this Form 483, for the inspection of Oct 1 – Oct 21, 2019. Each investigator has a profile showing what they cite most.
When was Magellan Diagnostics, Inc. inspected by FDA?
The inspection ran Oct 1 – Oct 21, 2019, and the Form 483 is dated October 21, 2019.
How do I get the full Form 483 for Magellan Diagnostics, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.