BSP Pharmaceuticals SpADecember 8, 2016

FDA 483 - BSP Pharmaceuticals SpA - December 08, 2016

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Record Details

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.

Company: BSP Pharmaceuticals SpA
Inspection Date: December 8, 2016
Product Type: Drugs
Office: FDA District Office — Silver Springs, Maryland
People: Francis A. Guidry (Investigator/Consumer Safety Officer)
Xiaokuang Lai

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ID · c8fc4c30-55b3-4faf-9131-aec2c37cf504