# BSP Pharmaceuticals SpA – FDA 483, Sep 8, 2026

Source: https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/db79cefd-005f-4995-ae45-d358ec8dbf58

> FDA 483 for BSP Pharmaceuticals SpA on September 08, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BSP Pharmaceuticals SpA
- Inspection Date: 2026-09-08
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: BSP Pharmaceuticals SpA in Latina, Italy, was cited for significant deficiencies in aseptic processing and contamination control during the manufacture of sterile drug products. The inspection revealed inadequate procedures to prevent microbiological contamination, poor aseptic practices by operators, and insufficient environmental monitoring. These issues pose a high risk to the sterility and quality of the firm's sterile drug products.

## Related Documents

- [483 - 2024-02-29](https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/46658879-500e-4fe3-a530-e8b26729b86a) — date: February 29, 2024
- [483 - 2022-03-23](https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/3c1888ce-6dae-4af7-9cc7-89243028fb7e) — date: March 23, 2022
- [483 - 2016-12-08](https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/c8fc4c30-55b3-4faf-9131-aec2c37cf504) — date: December 8, 2016
- [483](https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/6d9334e4-355f-4e21-ad72-92357fb9a296)

## Related Officers

- [Sudipan Karmakar](https://www.keypedia.com/people/sudipan-karmakar/3037fa5f-a982-4b25-ad94-df1c9e81c853)
- [Senior Consumer Safety Officer ](https://www.keypedia.com/people/marcus-f-yambot/a2266014-ae7e-4d64-aeba-a8cfb873f100)

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

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3