483
BSP Pharmaceuticals SpAFDA 483 - BSP Pharmaceuticals SpA - February 29, 2024
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Record Details
This FDA Form 483 was issued to BSP Pharmaceuticals S.p.A. in Latina Scalo, Italy, following an inspection. The inspection revealed deficiencies related to inadequate personnel monitoring during critical aseptic operations and non-sterile indirect product contact surfaces in aseptic drug product filling. These issues indicate potential risks to product sterility and quality.
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ID · 46658879-500e-4fe3-a530-e8b26729b86a