Micro Stamping Corp
Form 483 issued January 18, 2023 · Somerset, New Jersey
- Inspection
- Dec 7, 2022 – Jan 18, 2023
- Investigators
- Matthew W. Kyle· Monica L. Gutierrez
- 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.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures to control environmental conditions have…
- 03
Procedures for rework of nonconforming product have…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Matthew W. Kyle
3 documents · 2023–2025
Cites 820.25(b) (personnel) more than any other section. Most of their documents are for sites in New Jersey.
The firmMicro Stamping Corp history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
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?
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.