<span class="archive__title-prefix>Posts Categorized:</span> Enforcement

FDA continues its effort to limit the sale of unauthorized electronic nicotine delivery devices by posting ten warning letters last week to firms who target teenagers and other youth. They also continue to issue warning letters to firms that are advertising and distributing unapproved drug products for the prevention and treatment of COVID-19 infection.  On […]

The first quarter of 2020 is behind us, and with it, a fresh batch of warning letters sent by the FDA to food and dietary supplement companies. We’ve compiled a snapshot of all of the letters that posted from January through the end of March and organized them by category provided by the FDA for […]

No warning letters to drug firms were posted this week. We do provide one warning letter issued to a device firm, as well as one untitled letter issued to a stem cell firm. FDA also issued two warning letters to companies selling cannabidiol (CBD) containing products with claims of treating a variety of diseases, including […]

This week saw the continued posting of warning letters issued to those selling unapproved new drugs to prevent, diagnose, or treat COVID-19 infections. I’m sure these represent only the tip of the iceberg and will continue for a couple of years. Among the areas we cover, FDA posted one warning letter issued to a fertility […]

FDA continues to post warning letters to firms distributing unapproved products to diagnose, prevent and treat COVID-19 infections. Among the warning letters we follow, this week FDA posted one to a drug manufacturer, two to device firms, and one to a clinical investigator conducting studies on a device. DRUGS | Global Treat Srl (Romania) Global Treat […]

FDA posted three drug GMP warning letters this week to pharmaceutical firms, one to a compounding pharmacy, one to a GLP site, and two to device manufacturers.CDRH appears to have come alive again after a very slow 2019. Regarding the device warning letters, several were posted on the FDA site for an hour or so, […]

In the areas we cover, FDA posted three drug GMP warning letters including one sent to a fertility clinic governed by HCT/P regulations. The other two letters were to firms that manufacture OTC products. FDA also posted a warning letter to a firm in Ireland, Carahealth, for distributing unapproved and misbranded products related to coronavirus disease. Previously, […]

The EMA published information on two topics this week that will be of interest to firms who distribute product in the EU. The information addresses changes in due dates and application dates for: Completion of risk assessments regarding the potential for nitrosamine formation in chemically synthesized APIs Implementation of the new Medical Device Regulation (MDR) […]

On Friday, March 13, 2020, Covington & Burling hosted a Briefing Call titled “COVID-19: Evolving Considerations for the Life Sciences Industry” spearheaded by the firm’s Food, Drug and Device industry practice. Contributors cited were Grant Castle, Denise Esposito, Nigel Howard, Mike Imbroscio, Jen Plitsch, and Paula Katz. The discussion was wide-ranging and made some important […]

Enforcement this week included a collection of warning letters including three device warning letters and three drug GMP warning letters, including one to a fertility clinic governed under 21 CFR 1271.As with most warning letters in this product class, lack of adequate donor screening for the infectious disease was a prominent deficiency.We also see CDRH […]