Medical Devices Archives - EAS Consulting Group

Drug and Device Corner September 2020

Oct 1, 2020 | Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices

EAS would like to remind all eNews readers of the importance of an appointed U.S. Agent. The FDA recently deactivated the FDA registrations of 340 foreign establishments that failed to identify a U.S. Agent as required by FDA’s regulations. As we head into the FDA...

EAS Becomes GRMA Trusted Partner

Oct 1, 2020 | Cosmetics, Dietary Supplements, Drugs, EAS in Action, Medical Devices

The Global Retailer and Manufacturer Alliance (GRMA) recently confirmed EAS as a Trusted Consulting Partner for their member organizations. As a Trusted Partner EAS assists GRMA member suppliers and vendors with regulatory operational support. Acceptance into the...

Maintaining Compliance through Virtual Audits

Aug 26, 2020 | Cannabis, Cosmetics, Dietary Supplements, Drugs, Foods, Issue of the Month, Medical Devices, Tobacco, Veterinary

When the phone rings at EAS Consulting Group lately it is very often someone seeking assistance with Good Manufacturing Practices. While COVID-19 has caused major disruptions to global supply chains and manufacturing capabilities, FDA regulated industries forged ahead…

Drug and Device Corner August 2020

Aug 26, 2020 | Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices

The FDA recently published a laboratory testing method to assess the quality of finished hand sanitizer products. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. Due to the...

Drug and Device Corner July 2020

Aug 1, 2020 | Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices

The FDA is remaining vigilant in their monitoring of OTC hand sanitizer products. Their highest concerns, from a manufacturing and marketing perspective, are hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. They are also...

Drug and Device Corner June 2020

Jul 1, 2020 | Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices

OTC Monograph reform is here. The FDA recently distributed an email to all drug establishments registered as OTC manufacturers in preparation for the Over-The-Counter Monograph User Fee Program (OMUFA). OTC Monograph Reform legislation passed by congress this spring...