# FDA 483 - Italfarmaco S.A. - September 15, 2023

Source: https://www.keypedia.com/records/483/italfarmaco-sa/10ff96da-dc60-4165-a528-e78bcb56e19c

> FDA 483 for Italfarmaco S.A. on September 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Italfarmaco S.A.
- Inspection Date: 2023-09-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Italfarmaco S.A. in Alcobendas, Madrid, Spain, revealed that the firm's quality control unit failed to fully follow its responsibilities and procedures. This included inadequate analytical method transfer for a drug product, where an unqualified standard was used for release testing, and an insufficient deviation investigation that failed to ensure the use of a USP-certified standard. These issues indicate significant deficiencies in quality control and analytical testing practices.

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/samir-c-gala/904c34ee-013d-4663-a87a-9cbdbcf2b40e)

Company: https://www.keypedia.com/companies/italfarmaco-sa/1c87038a-ed84-4bfa-bb11-1fd51ce8eacd

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1