Media Quality Control Statement
Northeast Laboratory Services (NEL) produces and packages microbiological culture media at a
facility inspected by the Food and Drug Administration for compliance with the current Good
Manufacturing Practices regulations for Medical Devices and Diagnostic Products, CFR 21, Part 820.
Compliance with the CLSI Standard M22-A3, Quality Assurance for Commercially Prepared Microbiological
Culture Media is a criterion for release of invitro diagnostic products. Products must meet the
characteristics specified in the CLSI Standard before shipment release to your laboratory.
NEL also offers customized quality control testing. Product specific organisms and growth challenge
levels are available to meet specific requirements, including procedures which follow USP recommended
guidelines. Sterility confirmation testing with specified temperature and duration may also be
designed to meet unusual needs.
All manufactured lots of media are certified with a Certificate of Analysis (CoA), which outlines
the product testing that was performed.
Your satisfaction with our service and the quality of our products is the primary goal of the NEL
staff. Any questions or concerns you may have regarding NEL products should be addressed to the
Quality Assurance Department (x313) or our very friendly Customer Experience Department (x304 and x316).