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

CELL AND TISSUE THERAPIES | Chara Biologics Inc. Chara Biologics Inc. (Woodland Hills, CA) received an untitled letter on November 25, 2019, based on a review of their website.The firm makes drug-like claims for their non-homologous tissue therapy products, particularly the treatment of autism.FDA points out that this product is subject to additional oversight including […]

This week, FDA issued warning letters to 15 firms, (here is an example), that sell CBD products. These letters were issued by the Center for Food Safety and Applied Nutrition which govern nutritional supplements. FDA cites its authority over interstate commerce for food. The warning letters were based on reviews of websites which made claims […]

Enforcement was again busy in both the US and worldwide.  WHO published seven reports of inspections including one conducted for a bioequivalence study.  Europe published four reports of GMP non-compliance; one company had two sites inspected on the same day and the deficiencies identified were identical.  Here we cover the three FDA warning letters published […]

A busy week on the warning letter enforcement front. We provide one warning letter to a compounding pharmacy, one to an API manufacturer, and three to drug product manufacturers. For those who use recovered solvents in their manufacturing process, they would be well served to read FDA’s recommendations to Mylan on the topic of material […]

This is yet another week with a preponderance of warning letters issued by the Center for Tobacco Products.  One OTC manufacturer in China received a warning letter and we cover that below. In addition, Zydus Cadila reported that the FDA issued a warning letter to their Moraiya, India site, though this isn’t posted on the […]

A slow week for drug and device warning letters as FDA continues their enforcement focus on e-cigarette suppliers. Enforcement this week includes a lone GMP warning letter to a PET drug manufacturer. DRUGS | PETNET Solution Inc. PETNET Solution Inc.received a warning letter on October 17, 2019 based on the outcome of an inspection ending […]

We do not routinely cover enforcement actions by the Center for Tobacco Products, but we do address notable first of a kind action. Most warning letters from this Center are issued to outlets that sell cigarettes and tobacco products to underage individuals.  This warning letter is different and worth addressing because the product type is […]

The FDA Office of Generic Drugs recently published its 2018 Annual Report. The report addresses: the agency’s publication of guidance, policies, and procedures;product approvals and regulatory actions;and an overview of actions taken during the first year of GDUFA II. We will highlight some of the reported accomplishments and delve into others in more detail. Table […]

FDA issued the first warning letter that cites failure to comply with requirements of the November, 2013 Drug Supply Chain Security Act (DSCSA) amendments to the FD&C Act. This warning letter was issued to McKesson Corporation in San Francisco CA on February 7, 2019, based on observations from a form 483 issued at the close […]

Just when you think you know what to expect from the FDA, they go and shake things up. This is a developing story, but the implications for companies involved in clinical trials are clear. Both European and US regulators expect data integrity when it comes to clinical data and are increasingly willing to cite problems […]