Media Quality Control Statement
Northeast Laboratory Services 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
All product testing is certified on product/lot specific certificates of analysis (COA), which are available
for each manufactured lot.
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 Service Department (x304).