IncludeHealth
Form 483 issued November 1, 2023 · Dublin, Ohio
- Inspection
- Oct 24 – Nov 1, 2023
- Investigator
- Rosanna M. Goodrich
- Observations
- 5
- Pages
- 5
- FEI number
- 3021949949
In short: On November 1, 2023, FDA issued a Form 483 with 5 observations to IncludeHealth in Dublin, Ohio (FEI 3021949949) after an inspection that ran Oct 24 – Nov 1, 2023. The investigator was Rosanna M. Goodrich. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Validation of device software…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Procedures for quality audits have…
This inspection in context
Rosanna M. Goodrich
13 documents · 2015–2025
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Ohio.
The firmIncludeHealth history
The site's inspection history, in date order.
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 IncludeHealth?
FDA listed 5 observations on this Form 483, mostly about cAPA, management controls and design controls. The opening words of each observation are shown on this page.
Who inspected IncludeHealth?
Rosanna M. Goodrich is named on this Form 483, for the inspection of Oct 24 – Nov 1, 2023. Each investigator has a profile showing what they cite most.
When was IncludeHealth inspected by FDA?
The inspection ran Oct 24 – Nov 1, 2023, and the Form 483 is dated November 1, 2023.
How do I get the full Form 483 for IncludeHealth?
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.