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# CGMP Violations at Italy’s Eurosirel
- URL: https://www.fdaweb.com/cgmp-violations-at-italys-eurosirel/
- Published: 2024-11-26T12:00:00.000Z
- Updated: 2026-09-14T14:48:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158263

A 5/20-5/24 FDA inspection at Eurosirel S.P.A. in Milan, Italy, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/20 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eurosirel-spa-690733-11202024?ref=fdaweb.com) says the specific violations were:

- failure to conduct at least one test to verify the identity of each component of a drug product, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals; and
- failure to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA recommends that Eurosirel engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Eurosirel was told to correct violations promptly and to respond with a list of specific steps it has taken to correct violations and prevent their recurrence, with a schedule for completing the corrections.