# FDA 483 - Corden Pharma Bergamo SPA - Unknown Date

Source: https://www.keypedia.com/records/483/corden-pharma-bergamo-spa/ff65fcdd-9181-4fff-a666-9217d24db1b0

> FDA 483 for Corden Pharma Bergamo SPA on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Corden Pharma Bergamo SPA
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Corden Pharma Bergamo S.p.A., an API manufacturer in Treviglio, Italy, was cited for multiple deficiencies during an FDA inspection from September 24-27, 2018. Observations included inadequate out-of-specification investigations, lack of corrective and preventative actions for recurring complaints, and insufficient laboratory controls. The firm also lacked proper sanitization frequencies for water systems and contemporaneous batch documentation.

## Related Documents

- [483 - 2016-06-17](https://www.keypedia.com/records/483/corden-pharma-bergamo-spa/40851ff7-9af3-4136-812b-b771039380fa)

## Related Officers

- [Compliance Officer / Investigator](https://www.keypedia.com/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)

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

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