Transform Your Pharma Operations with AI-Powered Intelligence. Experience how Leucine's integrated platform brings together manufacturing, quality, and laboratory operations in one digital ecosystem. Schedule a personalized demo to see how our AI solutions can optimize your processes, ensure compliance, and drive operational excellence.
See How AI Transforms Your Shop Floor Operations.
Experience firsthand how Leucine's 10x MES digitalizes batch records, streamlines production, and provides real-time monitoring of your manufacturing operations. Schedule a personalized demo to discover how our AI-powered platform can enhance your productivity while maintaining compliance.
Experience AI-Driven Quality Management in Action.
See how Leucine's 10x QMS automates compliance workflows, streamlines change control, and ensures regulatory adherence. Schedule a demo to learn how our AI-powered platform can help you manage quality processes more efficiently while reducing compliance risks.
Discover Smart Laboratory Operations Management.
Watch how Leucine's 10x LES orchestrates your lab operations, automates documentation, and ensures data integrity. Schedule a demo to see how our AI-powered platform can accelerate your testing processes while maintaining audit-readiness.
Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| The separate or defined areas necessary to prevent contamination or mix-ups are deficient. Custom Analytics LLC |
12 Mar 2026 | Normal | Justification: Area Qualification is critical due to direct exposure of lab areas to non-controlled environments causing contamination risks. Excerpt: The pass-through counter has no physical barrier, allowing contaminants to enter the lab from the office area. View Details |
| Aseptic processing areas are deficient regarding the system for monitoring environmental conditions RayzeBio, Inc |
24 Feb 2026 | Normal | Justification: Room qualification failures directly involve area qualification processes affecting controlled environments. Excerpt: SOP-00195 criteria for differential pressure (DP) and/or ACPH not met. View Details |
| HEPA filters are not sealed around the perimeter. Empower Clinic Services, L.L.C. dba Empower Pharma |
14 Nov 2025 | Normal | Justification: Area Qualification is crucial as improper seals can compromise the sterility of ISO-classified rooms used for compounding. Excerpt: HEPA filters in the ISO Formulation and Filling Room were not properly sealed, with gaps noted. View Details |
| Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Celgene Corporation |
18 Jul 2025 | Normal | Justification: The qualification practices did not replicate true production settings, indicating a lack of understanding or procedural errors. Excerpt: Execution of qualification did not accurately simulate production conditions, failing to provide sufficient baseline data. View Details |
| Aseptic processing areas are deficient regarding the system for cleaning and disinfecting NerPharMa S.r.l. |
27 Jun 2025 | Normal | Justification: Failure to properly qualify areas based on systemic understanding, relying instead on vendor inputs. Excerpt: The biological indicator (BI) and chemical indicator (CI) locations were not determined by risk assessment. View Details |
View and learn more about FDA Inspections
with our comprehensive list of resources