Menasha Packaging Company LLC

Form 483 issued February 18, 2025 · Edison, New Jersey

Inspection
Feb 5 – Feb 18, 2025
Investigator
Esteban Beltran
Observations
4
Pages
5
FEI number
3010687142

In short: On February 18, 2025, FDA issued a Form 483 with 4 observations to Menasha Packaging Company LLC in Edison, New Jersey (FEI 3010687142) after an inspection that ran Feb 5 – Feb 18, 2025. The investigator was Esteban Beltran. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).

At a glance

Production & process controls and management controls account for 4 of 4 observations.

Production & process controls2
Management controls2

What FDA observed

Preview: the opening words of each observation
  1. 01

    Procedures to control environmental conditions have…

  2. 02

    Procedures for changes to a process…

  3. 03

    Individuals who conduct quality audits have direct responsibility for…

  4. 04

    Procedures for management review have…

The full 483

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

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This inspection in context

Questions about this 483

What did FDA find at Menasha Packaging Company LLC?

FDA listed 4 observations on this Form 483, mostly about production & process controls and management controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.

Who inspected Menasha Packaging Company LLC?

Esteban Beltran is named on this Form 483, for the inspection of Feb 5 – Feb 18, 2025. Each investigator has a profile showing what they cite most.

When was Menasha Packaging Company LLC inspected by FDA?

The inspection ran Feb 5 – Feb 18, 2025, and the Form 483 is dated February 18, 2025.

How do I get the full Form 483 for Menasha Packaging Company LLC?

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