Resources

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 […]

FDA Form 483 is an important enforcement action for regulated life sciences companies. They contain valuable information that can be analyzed to improve your product quality, reduce your compliance risk, and ultimately improve your business and customer outcomes. A single FDA Form 483 tells you exactly which areas to improve or correct to remain compliant […]

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.