Compass Health Brands Corp.
Form 483 issued February 27, 2026 · Brookpark, Ohio
- Inspection
- Feb 25 – Feb 27, 2026
- Investigator
- Laureen M. Geniusz
- Observations
- 1
- Pages
- 4
- FEI number
- 3005182235
In short: On February 27, 2026, FDA issued a Form 483 with 1 observation to Compass Health Brands Corp. in Brookpark, Ohio (FEI 3005182235) after an inspection that ran Feb 25 – Feb 27, 2026. The investigator was Laureen M. Geniusz. The most-cited regulation is 21 CFR 7.4.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.4.3
The inspection or other activities necessary for ensuring that purchased product meets specified purchasing requirements were…
This inspection in context
Laureen M. Geniusz
10 documents · 2015–2026
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Ohio.
The firmCompass Health Brands Corp. history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Compass Health Brands Corp.?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 7.4. The opening words of each observation are shown on this page.
Who inspected Compass Health Brands Corp.?
Laureen M. Geniusz is named on this Form 483, for the inspection of Feb 25 – Feb 27, 2026. Each investigator has a profile showing what they cite most.
When was Compass Health Brands Corp. inspected by FDA?
The inspection ran Feb 25 – Feb 27, 2026, and the Form 483 is dated February 27, 2026.
How do I get the full Form 483 for Compass Health Brands Corp.?
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.