ATZ Manufacturing
Form 483 issued July 24, 2025 · Marshall, Minnesota
- Inspection
- Jul 22 – Jul 24, 2025
- Investigator
- Clifford F. Long
- Observations
- 9
- Pages
- 8
- FEI number
- 3014653196
In short: On July 24, 2025, FDA issued a Form 483 with 9 observations to ATZ Manufacturing in Marshall, Minnesota (FEI 3014653196) after an inspection that ran Jul 22 – Jul 24, 2025. The investigator was Clifford F. Long. Most observations concern production & process controls and management controls.
At a glance
Observations span 4 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Quality system procedures and instructions…
- 02
Production processes were not developed to ensure that a device…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
Procedures for training and identifying training needs…
This inspection in context
Clifford F. Long
4 documents · 2023–2026
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Missouri.
The firmATZ Manufacturing history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ATZ Manufacturing?
FDA listed 9 observations on this Form 483, mostly about production & process controls, management controls and cAPA. The opening words of each observation are shown on this page.
Who inspected ATZ Manufacturing?
Clifford F. Long is named on this Form 483, for the inspection of Jul 22 – Jul 24, 2025. Each investigator has a profile showing what they cite most.
When was ATZ Manufacturing inspected by FDA?
The inspection ran Jul 22 – Jul 24, 2025, and the Form 483 is dated July 24, 2025.
How do I get the full Form 483 for ATZ Manufacturing?
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.