Magellan Diagnostics, Inc.
Form 483 issued June 29, 2017 · North Billerica, Massachusetts
- Inspection
- May 10 – Jun 29, 2017
- Investigators
- James W. Whitney· Suzanne M. Healy
- Observations
- 9
- Pages
- 11
- FEI number
- 1218996
In short: On June 29, 2017, FDA issued a Form 483 with 9 observations to Magellan Diagnostics, Inc. in North Billerica, Massachusetts (FEI 1218996) after an inspection that ran May 10 – Jun 29, 2017. The investigators were James W. Whitney and Suzanne M. Healy. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and design controls account for 9 of 9 observations.
Most cited: 21 CFR 820.30(g) (3×)
What FDA observed
Preview: the opening words of each observation- 01
Design validation did not ensure the device conforms to defined user…
- 02
Risk analysis is…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Procedmes for con ective and preventive action have…
This inspection in context
James W. Whitney
3 documents · 2017–2018
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Belgium.
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 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Magellan Diagnostics, Inc.?
FDA listed 9 observations on this Form 483, mostly about cAPA and design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Magellan Diagnostics, Inc.?
James W. Whitney and Suzanne M. Healy are named on this Form 483, for the inspection of May 10 – Jun 29, 2017. Each investigator has a profile showing what they cite most.
When was Magellan Diagnostics, Inc. inspected by FDA?
The inspection ran May 10 – Jun 29, 2017, and the Form 483 is dated June 29, 2017.
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.