YB Information

YB Inspection is a US-based manufacturer and consulting firm specializing in pharmaceutical visual inspection. We design and produce precision defect test kits, custom surrogate solutions, and provide expert consulting services to help pharmaceutical manufacturers build, validate, and maintain compliant visual inspection programs. Our Products: Particulate Defect Test Kits — Precision-manufactured containers with characterized particulate defects (fibers, glass, metal, rubber) at known sizes. Used for inspector qualification, Knapp testing, probability of detection studies, and automated inspection system validation. Cosmetic Defect Test Kits — Standardized container-closure defect sets featuring cracks, chips, scratches, and seal integrity defects for training and equipment qualification. Custom Surrogate Solutions — Formulations matched to your product’s refractive index, density, and viscosity. Ideal for controlled substances, high-value biologics, or any product where using actual drug product for inspection studies is impractical. Our Services: We consult on every aspect of visual inspection program development — from initial process design through regulatory submission. Our team supports AVI and SAVI recipe development, inspection station design and lighting optimization, inspector qualification program development, and ongoing compliance consulting aligned with USP <790>, USP <1790>, EU GMP Annex 1, and FDA expectations. Who We Work With: Pharmaceutical manufacturers producing injectable drug products — from small biotechs launching their first commercial product to large CMOs managing multiple inspection lines. Our clients include companies preparing for pre-approval inspections, responding to FDA 483 observations, or transitioning from manual to automated inspection. All products are manufactured in the United States. We ship globally. Free technical resources, regulatory guides, and articles available at ybinspection.com/resources.