# FDA 483 - BSP Pharmaceuticals SpA - February 29, 2024

Source: https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/46658879-500e-4fe3-a530-e8b26729b86a

> FDA 483 for BSP Pharmaceuticals SpA on February 29, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BSP Pharmaceuticals SpA
- Inspection Date: 2024-02-29
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: This FDA Form 483 was issued to BSP Pharmaceuticals S.p.A. in Latina Scalo, Italy, following an inspection. The inspection revealed deficiencies related to inadequate personnel monitoring during critical aseptic operations and non-sterile indirect product contact surfaces in aseptic drug product filling. These issues indicate potential risks to product sterility and quality.

## Related Documents

- [483 - 2016-12-08](https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/c8fc4c30-55b3-4faf-9131-aec2c37cf504)
- [483 - Unknown Date](https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/6d9334e4-355f-4e21-ad72-92357fb9a296)
- [483 - 2022-03-23](https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/3c1888ce-6dae-4af7-9cc7-89243028fb7e)

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [Deborah H. Schmiel](https://www.keypedia.com/people/deborah-h-schmiel/facfc308-52af-4353-902a-0d45d5d88020)

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

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