Resources

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 […]

    Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! Recalls for July 2017 Recalling Firm Class Product(s)  Reason Organic Herbal Supply I 11 products Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin AstraZeneca […]

We took a snapshot of the 9 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from “adulterated and misbranded drug products” to sites “failing to sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination.” From pharmaceuticals in Italy, Tennessee, and more, here they are […]

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! Recalls for the month June 2017 Recalling FirmClassProduct(s)ReasonComplete Pharmacy and Medical Solutions LLCI3 injectable productsNon-sterility: presence of mold confirmed by outside laboratory at the 14-day cultureSafecor Health, LLCII6 productsCGMP DeviationsHospiraIILevophed norepinephrine bitartrate, injection,GMP Deviation; A foreign stopper […]

China published their annual report of drug inspections for 2016 on June 2, 2017. The 31-page document reports on a variety of inspection types including but not limited to: pre-approval inspections, GMP certification inspections, and GMP follow-up inspections. The report is accompanied by tables and figures. For the most part, it is easily understood, but where discrepancies seem […]

August 3 update: we added 2 additional warning letters that were released by the FDA after we published this post on July 12, 2017. We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from “misbranded products” to sites “failing to investigate the unexplained […]