# FDA 483 - Corden Pharma Bergamo SPA - June 17, 2016

Source: https://www.keypedia.com/records/483/corden-pharma-bergamo-spa/40851ff7-9af3-4136-812b-b771039380fa

> FDA 483 for Corden Pharma Bergamo SPA on June 17, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Corden Pharma Bergamo SPA
- Inspection Date: 2016-06-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Farchemia S.r.l., an API manufacturer in Treviglio, Italy, was cited for significant quality control deficiencies during an FDA inspection. Observations included failure to test re-used API raw materials, lack of bulk hold studies for stored API, inadequate controls over laboratory computer systems, and deficient equipment cleaning validation. These issues indicate a lack of robust quality systems and data integrity.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/corden-pharma-bergamo-spa/ff65fcdd-9181-4fff-a666-9217d24db1b0)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/corden-pharma-bergamo-spa/8f926414-d5ef-49c4-be33-d7c81dfc55ea

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8