Resources

This series focuses on FDA enforcement surrounding drug GMP warning letters issued in FY2018. In parts one and two, we covered: Drug GMP warning letter trends since FY2013 Warning letters outside the U.S Enforcement of over-the-counter (OTC) and contract manufacturers/laboratories Import alerts associated with warning letters Data integrity deficiencies Here we look at the interval […]

This week there were a handful of warning letters issued to drug manufacturers. FDA continues an unrelenting focus on over-the-counter (OTC) (including cosmetics and sunscreen) and contract manufacturers. DRUGS | Becton Dickinson Medical Systems FDA published a close-out letter to Becton Dickinson Medical Systems regarding a warning letter the firm received on September 14, 2018. DRUGS […]

The theme of this year’s International Women’s Day is #BalanceforBetter. The campaign aims to reinforce the need for gender-balanced organizations and communities. At Redica Systems, we’re proud to say that 100%of our industry experts are women. We’re fortunate to have their expertise and experience on the team to help us develop and improve our platform, […]

This week we cover four warning letters: one to a device firm, two to drug manufacturers, and one to a cosmetics contract manufacturer. The two drug warning letters were issued to firms that manufacture OTC products, continuing FDA’s focus on this market segment. DEVICE:  Total Thermal Imaging, Inc (La Mesa, CA) received a warning letter […]

This week enforcement was busy with a GLP warning letter, warning letters to an API manufacturer and a pharmaceutical firm, a couple of compounding pharmacies, and a device firm. PRECLINICAL GLP: American Preclinical Services (Minneapolis, MN) received a warning letter on February 12, 2019 based on the outcome of an inspection ending April 13, 2018. […]

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 […]