Manufacturing and Quality
Manufacturing and Quality
FDA-registered, cGMP-compliant manufacturing with ISO 9001 and ISO 13485 certified quality management systems.
Vertically Integrated Manufacturing
Enzo manufactures the majority of its products at our headquarters in Farmingdale, New York. Our vertically integrated facility handles everything from raw material sourcing through final product packaging, ensuring complete control over quality at every stage. This approach enables us to deliver consistent, high-quality products while maintaining the flexibility to support custom manufacturing and OEM partnerships.
Quality Management System
Comprehensive quality framework ensuring product excellence
cGMP Compliance
Manufacturing under current Good Manufacturing Practice guidelines per 21 CFR Part 820
ISO 13485:2016
Certified quality management system for medical device and IVD manufacturing
ISO 9001:2015
Certified quality management for research-use-only products and services
Document Control
Rigorous SOPs, batch records, and change management for full traceability
QC Testing
In-process and final release testing including HPLC, ELISA, SDS-PAGE, and functional assays
CAPA Program
Systematic corrective and preventive action process for continuous improvement
Manufacturing Excellence
Partner with Our Manufacturing Team
Learn how Enzo’s manufacturing capabilities can support your product development and commercialization goals.