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

Source: https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/3c1888ce-6dae-4af7-9cc7-89243028fb7e

> 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: Foreign - CBER (Bioresearch Monitoring)
- Summary: An FDA inspection of BSP Pharmaceuticals S.p.A., a drug product manufacturer, revealed significant deficiencies in manufacturing process controls, complaint handling, equipment qualification, and electronic data integrity. The firm failed to establish adequate control procedures for media fills, properly investigate customer complaints, qualify equipment for its intended use, and ensure the accuracy and control of electronic data from computerized systems.

## 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 - 2024-02-29](https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/46658879-500e-4fe3-a530-e8b26729b86a)

## Related Officers

- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Compliance Officer](https://www.keypedia.com/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

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

Office: https://www.keypedia.com/offices/foreign-cber-bioresearch-monitoring/f1660531-9111-4f36-bf5d-b28bf0f3b54e