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Laws, Regulations, Guidance, and Concept Papers The week of February 11, 2018 was slow in the publication of guidance documents. The FDA published three, and the EMA did not publish any in the areas we follow. Health Canada and HPRA each published one item. There were also non-guidance documents and information published by EMA, MHRA, […]

The FDA published only seven warning letters this week. Of interest to us are two issued to finished drug manufacturers. The FDA continues their focus on OTC facilities that seemed to begin in 2017. Polaroisin International Co., Ltd. (Taiwan) received a warning letter on January 25, 2018, based on the outcome of an inspection ending […]

Here at FDAzilla, we’re excited to report that we have just collected our 20,000th FDA Warning Letter, going back to 2000, all completely searchable in our database.As you may know, the FDA automatically archives warning letters older than 5 years (and just did so with their 2012 collection last month). Yes it’s true: arguably, the […]

We took a snapshot of the 16 warning letters the FDA sent to pharmaceutical companies last month. The “Violation of the Month” was failing to bear adequate directions for the drug’s intended use. From pharmaceuticals in New Jersey, Japan, and more, here they are (starting with the most recent): Daito Kasei Kogyo Co.,Okayama,Japan – 2 violations:Failure to […]

We took a snapshot of the 15 warning letters (yes, 15) the FDA sent to pharmaceutical companies in December. Drug manufacturing violations ranged from failing to establish and follow adequate written procedures to failing to reveal consequences that could result from the use of a drug. From pharmaceuticals in San Diego, Korea, and more, here […]

We see a lot of people, all throughout the world, purchasing 483s from our FDA document store.  For example, this month customers came from Ireland, India, and China.  Here are some of the tools of the trade they purchased from us: FDA 483 Nobel Procera Services – Quebec, Canada – 12 Sep 2013 FDA 483 Catalent Pharma […]

A Guest Post from Oliver Yu, CTO, FDAzilla A core belief of drug manufacturing is that the drug alone is not the product of the pharmaceutical company. The drug and the documentation proving that the drug was made properly is the output of the pharmaceutical company.This belief is at the core of data integrity.If you […]

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 […]