Entries by Adam Parton

17025 Accreditation

LexaMed Obtains ISO 17025:2017 Accreditation LexaMed Ltd., a provider of contract laboratory and consulting services to the medical device, pharmaceutical industries and related industries, announced today that it had received ISO 17025:2017 certification from ANAB, an internationally known Notified Body registration firm. ISO 17025 is an internationally recognized standard that demonstrates that the company has […]

Visit LexaMed at Pharmacy Services 2017 Annual Meeting

Come and join us at the Pharmacy Services 2017 Annual Meeting on Tuesday, October 3, 2017.  David Brodersen and Adam Parton will be on hand to answer all of your regulatory compliance questions on USP chapters <797>/<800>, cleanroom qualifications, and environmental monitoring.   USP <797>/<800> – REGULATORY EXPECTATIONS  What are the challenges we all face […]

Jeff Martin Joins LexaMed’s Consulting Team

June 19, 2017 LexaMed is pleased to announce the addition of Jeff Martin to our consulting team. Jeff currently stands as the co-chair for the AAMI Industrial EO Standards working group.   With over twenty years of experience, Jeff has  national and international industry recognition for his subject matter expertise in terminal sterilization, Quality Systems and operations.

With Overwhelming Success, LexaMed is Continuing the Growth-Chek™ Promotion for New Clients

LexaMed is pleased by the overwhelming success through the first quarter of the Growth-Chek™ promotion and is continuing it through June 30,2017.  New Customers will continue to receive 50% off their first  Growth-Chek™ Order .  Excludes special order/custom made suspensions. When ordering, please mention internet ad for new clients.  Discount does not apply to shipping/handling […]

NRCM Certifies Xiao-qun Zeng

FOR IMMEDIATE RELEASE Xiao-qun Zeng Certified NRCM Registrant WASHINGTON, DC—July 26, 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. Ms. Zeng received her M.S. degree […]

LexaMed Presenting at BioOhio FDA Regulatory 101 Series: Medical Device Testing, Emerging Trends and Regulatory Expectations

August 18, 2016/in Events /by computol 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. For more information, click here   Where: Ascend Innovations […]

FDA Continuing to Issue 483’s to Compounding Pharmacies

FDA continues to issue 483s to compounding pharmacies for a lack evidence and cGMP framework in preventing/mitigating beta-lactam cross-contamination Warning Letters and significant FDA 483 observations continue to plague the compounding pharmacy industry with over 40% of compounders inspected receiving Warning Letters and nearly 100% receiving critical observations. One of the more common observations cited […]