GOJO Industries, Inc.
Form 483 issued August 5, 2022 · Wooster, Ohio
- Inspection
- Aug 1 – Aug 5, 2022
- Investigator
- Alan M. Barker
- Observations
- 3
- Pages
- 3
- FEI number
- 3011493299
In short: On August 5, 2022, FDA issued a Form 483 with 3 observations to GOJO Industries, Inc. in Wooster, Ohio (FEI 3011493299) after an inspection that ran Aug 1 – Aug 5, 2022. The investigator was Alan M. Barker. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure…
- 02
Established standards and sampling plans are not documented at…
- 03
Laboratory records do not include the initials or signature of a second person showing that the…
This inspection in context
Alan M. Barker
10 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Michigan.
The firmGOJO Industries, Inc. 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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GOJO Industries, Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected GOJO Industries, Inc.?
Alan M. Barker is named on this Form 483, for the inspection of Aug 1 – Aug 5, 2022. Each investigator has a profile showing what they cite most.
When was GOJO Industries, Inc. inspected by FDA?
The inspection ran Aug 1 – Aug 5, 2022, and the Form 483 is dated August 5, 2022.
How do I get the full Form 483 for GOJO Industries, 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.