# FDA 483 - BSP Pharmaceuticals SpA - March 23, 2022

Source: https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/68fa82b3-986f-4e5c-8ec1-dd7c474a41b0

> FDA 483 for BSP Pharmaceuticals SpA on March 23, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BSP Pharmaceuticals SpA
- Inspection Date: 2022-03-23
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: BSP Pharmaceuticals S.p.A. in Latina Scalo, Italy, was cited for significant deficiencies across its manufacturing operations. The inspection revealed issues with media fill program controls, inadequate complaint handling, improperly qualified equipment, and deficient control over electronic data and computerized systems. These observations indicate a lack of robust quality systems necessary for drug product manufacturing.

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- [483 - 2024-02-29](https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/58fbfc2c-ad6a-42b3-9087-1c14bd326f71)

## Related Officers

- [Yasmin Abset, Investigator](https://www.keypedia.com/people/yasmin-abset-investigator/326d5bcb-3cf5-44e4-94ee-dab7805c5205)
- [Thuy Nguyen, BMB1 Chief](https://www.keypedia.com/people/thuy-nguyen-bmb1-chief/941d13b3-f337-4530-97c1-519704126100)

Company: https://www.keypedia.com/companies/bsp-pharmaceuticals-spa/cbf52ec3-50e2-4cf1-9f81-f0f7a74473fc

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321