483
BSP Pharmaceuticals SpABSP Pharmaceuticals SpA – FDA 483, Dec 8, 2016
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.
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ID · c8fc4c30-55b3-4faf-9131-aec2c37cf504
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