About Us
Precision-Driven. Regulatory-Ready. US-Made.
YB Inspection is a premier manufacturer of visual inspection defect test kits and provider of consulting services for the pharmaceutical industry, based in the Research Triangle region of North Carolina.
Our Mission
We exist to provide pharmaceutical manufacturers with the highest-quality visual inspection tools and expertise available. Every defect test kit we produce, every surrogate solution we formulate, and every consulting engagement we undertake is driven by a single objective: ensuring that your visual inspection program meets the most rigorous regulatory standards while protecting patient safety.
Our team combines deep technical knowledge in pharmaceutical manufacturing, process validation, and regulatory compliance with hands-on experience across the full spectrum of visual inspection technologies — from manual inspection to fully automated systems.
What Sets Us Apart
Our Core Commitments
Quality Management System
Our comprehensive QMS ensures every product is manufactured, documented, and released under controlled conditions. We maintain full traceability from raw materials through final shipment.
US Manufacturing
All defect test kits and surrogate solutions are manufactured entirely in the United States, ensuring consistent quality, faster turnaround, and domestic shipping across all 50 states.
Audit-Ready Operations
Our facility and documentation are maintained in a state of constant audit readiness. We welcome and support customer site audits at any time — no advance preparation needed.
Regulatory Expertise
Deep working knowledge of FDA 21 CFR Part 211, USP <790>/<1790>, EU GMP Annex 1, and ICH guidelines ensures our products and services meet global regulatory expectations.
Industry Experience
We have developed solutions for CGT products, CDMOs, compounding pharmacies, biologics, and therapeutics — across every major container format used in injectable manufacturing.
Technical Partnership
We do not just supply products — we partner with your team to understand your specific challenges and develop solutions that integrate seamlessly into your quality system.
Quality Assurance
Our Quality Management System
Our QMS is designed to ensure the consistent production of high-quality defect test kits and surrogate solutions that meet or exceed the expectations of regulatory agencies worldwide. Key elements include:
Regulatory Alignment
Standards We Abide By
FDA 21 CFR Part 211
Current Good Manufacturing Practice for Finished Pharmaceuticals
USP <790>
Visible Particulates in Injections
USP <1790>
Visual Inspection of Injections
EU GMP Annex 1 (2022)
Manufacture of Sterile Medicinal Products
ISO 2859-1
Sampling Procedures for Inspection by Attributes
ICH Q9 / Q10
Quality Risk Management / Pharmaceutical Quality System
PDA Technical Reports
Visual Inspection Best Practices
Interested in a Site Audit or Partnership?
We are open for site audits and welcome the opportunity to demonstrate our capabilities. Contact us to schedule a visit or discuss your requirements.