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Inspection Record

BSP Pharmaceuticals S.p.A. — FDA 483 Findings

US FDAInspected 2018-09-21Published 2026-11-13 3 findingsOther quality systemEquipment and facility

View the regulator's official source The source document is always the basis for judgement.

Findings

1Other quality system

Procedure QC-001 for Management ofOut of Specification and Out-of-Alert limits is inadequate.

2Equipment and facility

There are discrepancies between the information included in the and the operations at the contract manufacturing facility.

3Other quality system

Pressure monitored during routine of the drug product is not representative of the pressure validated duringthe microbial retention studies.

A record as of the US FDA document published on 2026-11-13. Check the agency's announcements for any later corrective action, and rely on the original text. Translation and classification are machine-made.

Other records for this company

2022-03-31 · US FDA · 3 findings
BSP Pharmaceuticals S.p.A. findings history — including this company's other documentsAll US FDA findings US FDA documents, 2026 Go to Findings search
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