GOJO Industries LLC
Form 483 issued April 9, 2026
- Inspection
- Apr 6 – Apr 9, 2026
- Investigator
- Anna M. Spiros
- Observations
- 3
- Pages
- 4
- FEI number
- 1519176
In short: On April 9, 2026, FDA issued a Form 483 with 3 observations to GOJO Industries LLC (FEI 1519176) after an inspection that ran Apr 6 – Apr 9, 2026. The investigator was Anna M. Spiros. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
- 02
Drug products are not stored under appropriate conditions of temperature, humidity and light so that their…
- 03
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Anna M. Spiros
6 documents · 2024–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Michigan.
The firmGOJO Industries 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GOJO Industries LLC?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected GOJO Industries LLC?
Anna M. Spiros is named on this Form 483, for the inspection of Apr 6 – Apr 9, 2026. Each investigator has a profile showing what they cite most.
When was GOJO Industries LLC inspected by FDA?
The inspection ran Apr 6 – Apr 9, 2026, and the Form 483 is dated April 9, 2026.
How do I get the full Form 483 for GOJO Industries 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.