Our Manufacturing Practices


bacterial endotoxin testThe LAL Division of Wako Chemicals USA, Inc. manufactures Limusate Amebocyte Lysate (LAL) under the highest level of quality following United States Food and Drug Administration’s (FDA) Code of Federal Regulations (CFR) Title 21. The product is produced using automated filling machines in a Class 100 Clean Room that is pressurized. After production is completed, the product is taken through a series of quality testing before final release and approval by Quality Assurance (QA) and FDA. Quality over-site is provided to ensure that the Quality System remains intact at all times ensuring the highest level of product quality. All personnel have been properly trained on Current Good Manufacturing Processes (cGMP) and all processes are conducted as per the Standard Operating Procedures (SOP) established by the LAL Division. All of our equipment, processes, and facilities used in the production of FDA licensed products have been properly validated and approved by the FDA.

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