Resources

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 […]

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from sites failing to establish adequate quality control to failing to label products to bear adequate directions for use. From pharmaceuticals in China, New Mexico, and more, here they are (starting with the most recent): […]

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! DrugRecalls for September, 2017 Recalling FirmClassProduct(s)ReasonAndropharm LLCI2 products, recall of all lots within expiryMarketed without an approved NDA/ANDA: product label states it contains anabolic steroids.Bestherbs Coffee LLCINew Kopi Jantan Tradisional Natural Herbs CoffeeMarketed without an approved NDA/ANDA: […]

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! Recalls for August, 2017 Recalling FirmClassProduct(s)ReasonC.O. TruxtonI6 productsLabeling: Labeled mix up, potentially mislabeledBrian P. RichardsonICaverFlo Natural Herbal CoffeeMarketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milkGenetic Edge CompoundsIGEC LX […]