EUROSIREL SPA
Form 483 issued May 24, 2024 · Cusago, Italy
- Inspection
- May 20 – May 24, 2024
- Observations
- 5
- Pages
- 2
- FEI number
- 3015892095
In short: On May 24, 2024, FDA issued a Form 483 with 5 observations to EUROSIREL SPA in Cusago, Italy (FEI 3015892095) after an inspection that ran May 20 – May 24, 2024. Most observations concern production and materials.
At a glance
Production and materials account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Specific identification tests are not conducted on components that have been accepted based on the…
- 02
Each component is not added to the batch by one person and verified…
- 03
The batch production and control records are deficient in that they do not include documentation of…
- 04
Written records of major equipment use are not included…
This inspection in context
Questions about this 483
What did FDA find at EUROSIREL SPA?
FDA listed 5 observations on this Form 483, mostly about production, materials and quality system. The opening words of each observation are shown on this page.
When was EUROSIREL SPA inspected by FDA?
The inspection ran May 20 – May 24, 2024, and the Form 483 is dated May 24, 2024.
How do I get the full Form 483 for EUROSIREL SPA?
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.