ILMO Products Company

Form 483 issued March 28, 2024 · Jacksonville, Illinois

Inspection
Mar 26 – Mar 28, 2024
Investigator
Conner N. Mann
Observations
6
Pages
6
FEI number
1454831

In short: On March 28, 2024, FDA issued a Form 483 with 6 observations to ILMO Products Company in Jacksonville, Illinois (FEI 1454831) after an inspection that ran Mar 26 – Mar 28, 2024. The investigator was Conner N. Mann. Most observations concern quality system and packaging & labeling.

At a glance

Observations span 4 systems, led by quality system.

Quality system2
Packaging & labeling1
Production1
Facilities & equipment1
Other1

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    Strict control is not exercised over labeling issued for use in…

  2. 02

    Written production and process control procedures are not followed in the execution of production and process…

  3. 03

    Appropriate controls are not exercised over computers or related systems to assure that changes in master…

  4. 04

    The responsibilities and procedures applicable to the quality control unit are not in…

2 more observations

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

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at ILMO Products Company?

FDA listed 6 observations on this Form 483, mostly about quality system, packaging & labeling and production. The opening words of each observation are shown on this page.

Who inspected ILMO Products Company?

Conner N. Mann is named on this Form 483, for the inspection of Mar 26 – Mar 28, 2024. Each investigator has a profile showing what they cite most.

When was ILMO Products Company inspected by FDA?

The inspection ran Mar 26 – Mar 28, 2024, and the Form 483 is dated March 28, 2024.

How do I get the full Form 483 for ILMO Products Company?

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.

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