Axiobionics, LLC
Form 483 issued November 22, 2024 · Ann Arbor, Michigan
- Inspection
- Nov 19 – Nov 22, 2024
- Investigator
- David Gasparovich
- Observations
- 3
- Pages
- 4
- FEI number
- 3008525454
In short: On November 22, 2024, FDA issued a Form 483 with 3 observations to Axiobionics, LLC in Ann Arbor, Michigan (FEI 3008525454) after an inspection that ran Nov 19 – Nov 22, 2024. The investigator was David Gasparovich. Most observations concern cAPA and management controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Management with executive responsibility has not reviewed the suitability and effectiveness of the quality…
- 02
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 03
Procedures for collective and preventive action have…
This inspection in context
David Gasparovich
8 documents · 2015–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Illinois.
The firmAxiobionics, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.20(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Axiobionics, LLC?
FDA listed 3 observations on this Form 483, mostly about cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Axiobionics, LLC?
David Gasparovich is named on this Form 483, for the inspection of Nov 19 – Nov 22, 2024. Each investigator has a profile showing what they cite most.
When was Axiobionics, LLC inspected by FDA?
The inspection ran Nov 19 – Nov 22, 2024, and the Form 483 is dated November 22, 2024.
How do I get the full Form 483 for Axiobionics, LLC?
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.