Fuller Industries, Inc
Form 483 issued March 26, 2025 · Great Bend, Kansas
- Inspection
- Mar 18 – Mar 26, 2025
- Investigator
- Conner N. Mann
- Observations
- 5
- Pages
- 7
- FEI number
- 1922337
In short: On March 26, 2025, FDA issued a Form 483 with 5 observations to Fuller Industries, Inc in Great Bend, Kansas (FEI 1922337) after an inspection that ran Mar 18 – Mar 26, 2025. The investigator was Conner N. Mann. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 02
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and…
- 04
Results of stability testing are not used…
This inspection in context
Conner N. Mann
7 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Kansas.
The firmFuller Industries, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(b)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fuller Industries, Inc?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Fuller Industries, Inc?
Conner N. Mann is named on this Form 483, for the inspection of Mar 18 – Mar 26, 2025. Each investigator has a profile showing what they cite most.
When was Fuller Industries, Inc inspected by FDA?
The inspection ran Mar 18 – Mar 26, 2025, and the Form 483 is dated March 26, 2025.
How do I get the full Form 483 for Fuller 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.