BSP Pharmaceuticals SpAFebruary 29, 2024

FDA 483 - BSP Pharmaceuticals SpA - February 29, 2024

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An FDA inspection of BSP Pharmaceuticals S.p.A. in Latina Scalo, Italy, revealed two significant observations related to aseptic processing. The firm was cited for inadequate personnel monitoring during critical Grade A RABS setup operations and for using non-sterile indirect product contact surfaces in aseptic drug product filling.

Company: BSP Pharmaceuticals SpA
Inspection Date: February 29, 2024
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Michael R. Shanks (Investigator)
Deborah H. Schmiel

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ID · 58fbfc2c-ad6a-42b3-9087-1c14bd326f71