Jet Pulverizer Co Inc

Form 483 issued February 20, 2024 · Moorestown, New Jersey

Inspection
Feb 14 – Feb 20, 2024
Observations
2
Pages
2
FEI number
2227260

In short: On February 20, 2024, FDA issued a Form 483 with 2 observations to Jet Pulverizer Co Inc in Moorestown, New Jersey (FEI 2227260) after an inspection that ran Feb 14 – Feb 20, 2024. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).

At a glance

Facilities & equipment and quality system account for 2 of 2 observations.

Facilities & equipment1
Quality system1

Most cited: 21 CFR 211.67 (1×) · 211.25 (1×)

What FDA observed

Preview: the opening words of each observation

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

  1. 01

    Failure to establish adequate written procedures for cleaning equipment and its release for use…

  2. 02

    Failure to ensure training is regularly conducted by qualified individuals and covers, at a minimum, the…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at Jet Pulverizer Co Inc?

FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.

When was Jet Pulverizer Co Inc inspected by FDA?

The inspection ran Feb 14 – Feb 20, 2024, and the Form 483 is dated February 20, 2024.

How do I get the full Form 483 for Jet Pulverizer Co Inc?

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