Resources

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! DrugRecalls for December, 2017 Recalling FirmClassProduct(s)ReasonEZ Weight Loss TX LLCI2 LaBri’s Body Health productsMarketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: products found to be tainted with sibutramine making these unapproved drugsThe Ampt […]

We took a snapshot of the 7 warning letters the FDA sent to food companies last month. Food violations ranged from failing to remove the presence of Listeria to failing to provide screening against pests. From companies in Brooklyn, Georgia, and more, here they are (starting with the most recent): Maine Natural Health, Inc., Warren, […]

Homeopathic Products: What Are They and Why Should You Care? Among the unique enforcement actions in fiscal year 2017 are a cluster of warning letters and recalls of homeopathic products. 2017 saw as many warning letters issued to these firms as were issued between 2009 and 2013. This is a marked change from previous years beginning in 2009 […]

FDA Enforcement Actions Against Firms in South Korea Several years ago, the FDA began, in earnest, to take more enforcement actions against sites outside the US than they did against sites within the US. This was simply because the majority of drugs and APIs are produced outside the US. If we look at warning letters, we initially […]

For Novel Medicinal Products Part I (The FDA’s Guidance), click here. The EMA and GMPs for Advance Therapy Medicinal Products by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Manufacturing and testing of Advance Therapy Medicinal Products (ATMPs) is generally significantly different from processes used in chemical synthesis of small molecules or cell-based […]

The FDA and Its New Guidance on Regenerative Medicine Drugs by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief The four guidance we address here are part of the FDA’s announced ‘comprehensive regenerative medicine policy framework’ and support implementation of provisions in the 21st Century Cures Act. The FDA is actively supporting the […]

We see a lot of people, all throughout the world, purchasing 483s from our FDA document store. For example, this month customers came from Japan, theUnited States, China, and Switzerland. Here are some of the tools of the trade they purchased from us starting with the most recent: FDA 483 Maquet Cardiopulmonary Ag – Hechingen, […]

We took a snapshot of the 3 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to have correct expiration dates to failing to investigate the unexplained. From pharmaceuticals in China and India only, here they are (starting with the most recent): Hangzhou Facecare Cosmetics Co. Ltd., Hangzhou, […]

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to prevent “mix-ups” to failing to adequately investigate. From pharmaceuticals in Wisconsin, India, and more, here they are (starting with the most recent): Guangdong Zhanjiang Jimin Pharmaceutical Co., Zhangjiang City, China – […]

The FDA has been on a bit of a tear in publishing guidance for devices and generic drugs. Here we address the CDRH guidance issued between September 29th and October 25th 2017 and provide summaries of their content. Seven guidance listed below are final, and one is published for comment. Many are associated with requirements in the […]