Micro Stamping Corp

Form 483 issued January 18, 2023 · Somerset, New Jersey

Inspection
Dec 7, 2022 – Jan 18, 2023
Observations
5
Pages
6
FEI number
1000222372

In short: On January 18, 2023, FDA issued a Form 483 with 5 observations to Micro Stamping Corp in Somerset, New Jersey (FEI 1000222372) after an inspection that ran Dec 7, 2022 – Jan 18, 2023. The investigators were Matthew W. Kyle and Monica L. Gutierrez. Most observations concern cAPA and production & process controls.

At a glance

CAPA and production & process controls account for 4 of 5 observations.

CAPA2
Production & process controls2
Records & documents1

What FDA observed

Preview: the opening words of each observation
  1. 01

    Procedures for corrective and preventive action have…

  2. 02

    Procedures to control environmental conditions have…

  3. 03

    Procedures for rework of nonconforming product have…

  4. 04

    Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…

1 more observation

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 Micro Stamping Corp?

FDA listed 5 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. The opening words of each observation are shown on this page.

Who inspected Micro Stamping Corp?

Matthew W. Kyle and Monica L. Gutierrez are named on this Form 483, for the inspection of Dec 7, 2022 – Jan 18, 2023. Each investigator has a profile showing what they cite most.

When was Micro Stamping Corp inspected by FDA?

The inspection ran Dec 7, 2022 – Jan 18, 2023, and the Form 483 is dated January 18, 2023.

How do I get the full Form 483 for Micro Stamping Corp?

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