1Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Inspection Record
BSP Pharmaceuticals S.p.A. — FDA 483 Findings
Inspectors Yasamin AmeriThe inspectors who signed the published document.Inspector lookup
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Findings
2Other quality system
Input to and output from the computer, related systems of formulas, and records or data are not checked for accuracy.
3Process validation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Similar findings at other companies
GRM selected findings from the same type of public document whose wording is close to a finding in this document. One per company.
- Packagina On Demand, Inc.2024-09-27 · US FDASimilar to finding 1 Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
- Lyophilization Services of New England, Inc. dba PCI Pharma Services2026-06-10 · US FDASimilar to finding 1 Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
- Phoenix Innovative Healthcare Manufactures Private Limited2024-09-27 · US FDASimilar to finding 1 Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and suitably located to facilitate operations…
- Hybrid Pharma LLC2026-08-27 · US FDASimilar to finding 1 Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use…
- Kaysersberg Pharmaceuticals SAS2016-07-19 · US FDASimilar to finding 3 Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for…
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.