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 |
|---|---|---|---|
| Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair. Aurobindo Pharma Ltd. |
05 Sep 2025 | Normal | Justification: Facility design is directly related to the observation as the structural integrity issues compromise a clean and safe environment. Excerpt: Leaky, corroded, and perforated ceilings and rainwater seeping through shipping doors and ceiling tiles. View Details |
| Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations. GenoGenix, LLC |
18 Jul 2025 | Normal | Justification: Facility Design impacts environmental conditions, affecting ability to maintain controlled environment. Excerpt: Wood-like material for door frames, ceiling cassettes with non-cleanable surfaces. View Details |
| Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters Lupin Limited |
17 Jul 2025 | Normal | Justification: The design and maintenance of the facility's airflow systems are critical to ensuring controlled environments are sustained, affecting Facility Design. Excerpt: airflow swirling towards the ceiling rather than following the expected laminar flow path View Details |
| Buildings used in the manufacture, processing, packing, or holding of a drug product do not have suitable construction to facilitate cleaning, maintenance, and proper operations. NATCO Pharma Limited |
19 Jun 2025 | Normal | Justification: Facility design flaws are evident by the inability to observe operations from designated viewing areas, impairing aseptic processing control. Excerpt: Your Unit (b)(4) aseptic processing area is not adequately visible from the (b)(4) viewing windows. View Details |
| is not maintained in a state of good repair Capricor, Inc. |
30 May 2025 | Normal | Justification: Facility Design is directly linked as the observation involves physical state and suitability of the manufacturing area. Excerpt: Specifically, (b) (4) was observed on the (b) (4) inside the ISO(b) Room (b) (4) manufacturing suite (Production (b) (4). View Details |
View and learn more about FDA Inspections
with our comprehensive list of resources