Resources

FDA posted a dozen warning letters and five advisory letters to companies illegally selling dietary supplements meant to treat or cure Alzheimer’s disease. This appears to be a shot across the bow regarding actions that FDA will be taking to improve the safety of dietary supplements. We cover four other warning letters here, including one […]

An unusual amount of activity around the Immunomedics 483 started at the beginning of December 2018 and continued into February. Capital management firms made the majority of purchases, so we knew something must be amiss. If you’re unfamiliar with Immunomedics, it’s a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer. […]

This week there were three warning letters, all for drug GMP failures. Each company was placed on import alert. DRUGS: Hangzhou Zhongbo Industrial Co., Ltd. (Zhejiang, China) received a warning letter on November 27, 2018 based on the outcome of an inspection ending April 27, 2018. The firm is yet another OTC manufacturer to receive a […]

Now that the government shutdown is over, at least for 3 weeks, FDA has started publishing warning letters. We have two from this week: one to a finished pharmaceuticals manufacturer, and one to a manufacturer of human cells, tissues, and cellular products.   DRUGS: Hangzhou Guoquang Touring Commodity Co. Ltd. (Zhejiang, China) received a warning letter […]

Maintaining a proactive approach to regulatory compliance is challenging in the medtech and pharma industries. Staying on top of FDA (and other health agency) regulations, especially when you get issued an FDA Form 483 can be stressful for your quality, compliance, and operations teams. We built this guide so you can understand FDA expectations following […]

No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere that focused on aseptic processing and data integrity. Akorn, Inc. (Decatur, IL) received a warning letter on January 4, 2019 based on the outcome of an inspection at their site ending May 16, 2018. […]

It’s been a light couple of weeks due to the partial government shutdown. Here are the latest recalls. This post is no longer available.

Enforcement: Recalls:Classified recalls from 21 firms, Unclassified recalls from 13 firmsClass II and III recallsImport Alerts:A limited number of import alerts from Israel and China Warning Letters:Drug Manufacturers:  4 warning lettersHuman Cells/Tissues: 2 warning lettersCompounding Pharmacies:  1 warning letter for an inspection ending in 2016 (not a typo)Device Firms: 1 warning letter483s:3 483s sent, one to a Phizer […]

The House, the Senate, and the President of the United States failed to reach an agreement on a short-term spending bill to extend funding for seven federal departments including the Department of Health and Human Services that funds the FDA. As a result, the FDA has furloughed 41% of its staff—some 7,000+ employees in total. […]

We took a snapshot of the 2 warning letters the FDA sent to food companies in November. Violations included adulterated beef and kratom contaminated with salmonella. Avalon Packaging, American Fork, UT – Violations were grouped into three categories: Pathogen Findings, CGMP Violations, and New Dietary Ingredient.Pathogen Findings:FDA collected three raw kratom samples that were to […]