# FDA 483 - BSP Pharmaceuticals SpA - December 08, 2016

Source: https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/c8fc4c30-55b3-4faf-9131-aec2c37cf504

> FDA 483 for BSP Pharmaceuticals SpA on December 08, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BSP Pharmaceuticals SpA
- Inspection Date: 2016-12-08
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: BSP Pharmaceuticals S.p.A. in Latina, Italy, received an FDA Form 483 citing significant deficiencies in their drug manufacturing operations. The inspection revealed issues with equipment validation, computer system data integrity, incomplete batch records, and inadequate employee training. These observations highlight concerns regarding the firm's adherence to cGMP regulations and overall quality control processes.

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## Related Officers

- [Investigator/Consumer Safety Officer](https://www.keypedia.com/people/francis-a-guidry/fd6d2a17-7f94-4f7c-8284-ad1f07d703e9)
- [Xiaokuang Lai](https://www.keypedia.com/people/xiaokuang-lai/6c25851d-0954-4f42-8f14-c2e0382e6815)

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

Office: https://www.keypedia.com/offices/fda-district-office-silver-springs-maryland/88352440-432a-426b-ad8b-f768d4460a19