NRCM Certifies Xiao-qun Zeng- Aug. 19, 2016

Xiao-qun Zeng, Project Team Lead, LexaMed, Ltd, Toledo, OH, is now a Registrant of the National Registry of Certified Microbiologists (NRCM). On June 27, 2016, she became certified as a Specialist Microbiologist in Pharmaceutical and Medical Device Microbiology. Read More

FDA Issuing 483’s to Compounding Pharmacies- Aug 18, 2016

Warning Letters and significant FDA 483 observations continue to plague the compounding pharmacy industry with over 40% of compounding pharmacies inspected receiving Warning Letters and nearly 100% receiving critical observations. One of the more common observations cited by the FDA directly relates to the implementation of manufacturing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam drugs. Read More

LexaMed Presenting at BioOhio FDA Regulatory 101 Series: Medical Device Testing, Emerging Trends and Regulatory Expectations- Aug. 18, 2016

Come and join us at the BioOhio Meeting on Wednesday, September 28, 2016. LexaMed President, Bob Reich will be speaking Join us to learn more about FDA requirements for reprocessing reusable medical devices (cleaning/disinfection/sterilization), AET, Environmental Isolates and Quality Management. Read More

Laboratory Testing

LexaMed ISO 13485 certified laboratories provide quality services in routine microbiology and chemistry testing, specific project testing, client R&D, sterilization, and packaging. Dedicated laboratory space and personnel are available for the execution of custom R&D protocols.

Microbial Suspensions

LexaMed manufactures “Growth-Chek” Microbial Suspensions that are derived from cultures traceable to a recognized culture collection identified in USP. They are specially prepared for simplifying the performance of Quality Control measures for growth media.

Consulting Services

LexaMed offers consulting services in all aspects of the pharmaceutical, medical device and biotechnology industries. We integrate our subject matter experts into problem-solving teams to provide the most cost-effective and practical solutions to our clients’ specific needs.

LexaMed offers consulting services to the pharmaceutical, medical device and biotechnology industries, provides microbiology and chemistry testing in our corporate laboratories, and manufactures microbial suspensions. LexaMed compliments its consulting and validation services, laboratory operations and microbial suspension product line with additional integrated services in quality management systems, regulatory assistance, auditing, testing programs for sterilization of packaging systems, cleaning and sterilization validation of reusable devices, client research & development, environmental monitoring, container closure integrity testing, and training and seminars. Please contact us to discuss your specific requirements and determine how our staff can best support you and your operation.