Spineology, Inc
Form 483 issued February 15, 2022 · Saint Paul, Minnesota
- Inspection
- Feb 8 – Feb 15, 2022
- Investigators
- Albert L. Nguyen· Christina L. Bigham
- Observations
- 2
- Pages
- 4
- FEI number
- 3003179719
In short: On February 15, 2022, FDA issued a Form 483 with 2 observations to Spineology, Inc in Saint Paul, Minnesota (FEI 3003179719) after an inspection that ran Feb 8 – Feb 15, 2022. The investigators were Albert L. Nguyen and Christina L. Bigham. Most observations concern production & process controls and design controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and design controls account for 2 of 2 observations.
Most cited: 21 CFR 820.70(i) (1×) · 820.30(g) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Software used as pail of the quality system has not been adequately validated for its intended…
- 02
Risk analysis is…
This inspection in context
Albert L. Nguyen
4 documents · 2020–2024
Cites 820.70(a) (production and process 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 820.70(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Spineology, Inc?
FDA listed 2 observations on this Form 483, mostly about production & process controls and design controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Spineology, Inc?
Albert L. Nguyen and Christina L. Bigham are named on this Form 483, for the inspection of Feb 8 – Feb 15, 2022. Each investigator has a profile showing what they cite most.
When was Spineology, Inc inspected by FDA?
The inspection ran Feb 8 – Feb 15, 2022, and the Form 483 is dated February 15, 2022.
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.