483
BSP Pharmaceuticals SpABSP Pharmaceuticals SpA – FDA 483, Feb 29, 2024
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
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