Dyno Manufacturing, Inc
Form 483 issued November 1, 2024 · Madison, Illinois
- Inspection
- Oct 28 – Nov 1, 2024
- Observations
- 3
- Pages
- 3
- FEI number
- 3017219182
In short: On November 1, 2024, FDA issued a Form 483 with 3 observations to Dyno Manufacturing, Inc in Madison, Illinois (FEI 3017219182) after an inspection that ran Oct 28 – Nov 1, 2024. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no written testing program designed to assess the stability…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
The responsibilities and procedures applicable to the quality control unit are not…
This inspection in context
Questions about this 483
What did FDA find at Dyno Manufacturing, Inc?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
When was Dyno Manufacturing, Inc inspected by FDA?
The inspection ran Oct 28 – Nov 1, 2024, and the Form 483 is dated November 1, 2024.
How do I get the full Form 483 for Dyno Manufacturing, Inc?
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.