Intercos Europe SPA
Form 483 issued March 15, 2024 · Agrate Brianza, Italy
- Inspection
- Mar 11 – Mar 15, 2024
- Investigator
- Joseph A. Piechocki
- Observations
- 5
- Pages
- 5
- FEI number
- 1000181428
In short: On March 15, 2024, FDA issued a Form 483 with 5 observations to Intercos Europe SPA in Agrate Brianza, Monza e della Brianza (FEI 1000181428) after an inspection that ran Mar 11 – Mar 15, 2024. The investigator was Joseph A. Piechocki. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 02
The number of containers to be sampled is not…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Joseph A. Piechocki
19 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmIntercos Europe SPA history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intercos Europe SPA?
FDA listed 5 observations on this Form 483, mostly about materials, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Intercos Europe SPA?
Joseph A. Piechocki is named on this Form 483, for the inspection of Mar 11 – Mar 15, 2024. Each investigator has a profile showing what they cite most.
When was Intercos Europe SPA inspected by FDA?
The inspection ran Mar 11 – Mar 15, 2024, and the Form 483 is dated March 15, 2024.
How do I get the full Form 483 for Intercos Europe SPA?
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