FDA Intel

Fuller Industries, Inc

Form 483 issued February 17, 2023 · Great Bend, Kansas

Investigator
Torrey M. Ward
Observations
7
Pages
4
FEI number
1922337

In short: On February 17, 2023, FDA issued a Form 483 with 7 observations to Fuller Industries, Inc in Great Bend, Kansas (FEI 1922337). The investigator was Torrey M. Ward. Most observations concern laboratory controls and quality system.

At a glance

Laboratory controls and quality system account for 5 of 7 observations.

Laboratory controls4
Quality system1
Production1
Materials1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.160(b)

    Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…

  2. 02
    21 CFR 211.166(a)

    There is no written testing program designed to assess the stability…

  3. 03
    21 CFR 211.165(f)

    Drug products failing to meet established specifications and quality control…

  4. 04
    21 CFR 211.194(a)(1)

    Laboratory records are deficient in that they do not include a description and identification of the…

3 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Torrey M. Ward

13 documents · 2021–2023

Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Iowa.

The firm

Fuller Industries, Inc history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.160(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Fuller Industries, Inc?

FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.

Who inspected Fuller Industries, Inc?

Torrey M. Ward is named on this Form 483. Each investigator has a profile showing what they cite most.

When was Fuller Industries, Inc inspected by FDA?

This Form 483 is dated February 17, 2023.

How do I get the full Form 483 for Fuller Industries, Inc?

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