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# CGMP Violations at Italian Drug Plan
- URL: https://www.fdaweb.com/cgmp-violations-at-italian-drug-plan/
- Published: 2024-09-17T12:00:00.000Z
- Updated: 2026-09-14T14:41:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157798

An FDA review of records supplied by Industria Farmaceutica Nova Argentia in Milan, Italy, a manufacturer of over-the-counter drugs, found violations of current good manufacturing practice (CGMP) regulations. A 9/9 [Untitled Letter](https://www.fda.gov/media/181912/download?ref=fdaweb.com) says specific violations were:

- failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient;
- failure to conduct at least one test to verify the identity of each component of a drug product; and
- failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products.

The letter notes that the firm released purportedly sterile finished drug products using a parametric release approach rather than sterility testing. “The CGMP violations described throughout this letter demonstrate an ineffective Quality System,” the agency says. “FDA is concerned that you do not have appropriate oversight for a parametric release approach for your finished drug products.”

FDA acknowledges that the firm ceased production of redacted drug products for the U.S. market and asks whether it intends to resume manufacturing production for the U.S. market at that facility in the future.

Industria Farmaceutica was told to respond with a list of specific steps it has taken to address any violations and prevent their recurrence, with a schedule for completing the corrections.