Spineology, Inc
Form 483 issued March 31, 2017 · Saint Paul, Minnesota
- Inspection
- Mar 21 – Mar 31, 2017
- Investigator
- Susan M. Matthias
- Observations
- 5
- Pages
- 2
- FEI number
- 3003179719
In short: On March 31, 2017, FDA issued a Form 483 with 5 observations to Spineology, Inc in Saint Paul, Minnesota (FEI 3003179719) after an inspection that ran Mar 21 – Mar 31, 2017. The investigator was Susan M. Matthias. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the contr ol of storage areas and stock rooms have…
- 02
Products that do not conform to specifications…
- 03
Procedures for corrective and preventive action have…
- 04
The device history record does not demonstrate that the device was manufactured in accordance with…
This inspection in context
Susan M. Matthias
10 documents · 2013–2019
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Minnesota.
The firmSpineology, Inc history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.150
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Spineology, Inc?
FDA listed 5 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Spineology, Inc?
Susan M. Matthias is named on this Form 483, for the inspection of Mar 21 – Mar 31, 2017. Each investigator has a profile showing what they cite most.
When was Spineology, Inc inspected by FDA?
The inspection ran Mar 21 – Mar 31, 2017, and the Form 483 is dated March 31, 2017.
How do I get the full Form 483 for Spineology, 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.