FDA posted 7 warning letters this week including 2 warning letters to Medtronic regarding non-conformance that resulted in a Class I recall of a defibrillator earlier in 2018. In addition, warning letters were issued to 1 firm in Canada and 1 firm in China. And, in the largest coordinated enforcement effort in the FDA’s history, 1,300 warning letters were issued to a single industry.
When site personnel complete subjects’ e-diaries, bad things happen. Don’t let them happen to your company! This post explains the top 3 steps to avoid a costly ePRO 483.
The FDA posted 13 new warning letters this week including 7 issued by the Center for Tobacco Products, 1 to a device firm, and 1 to a compounding pharmacy. Four warning letters regarding 21 websites illegally marketing unapproved and misbranded versions of opioids including tramadol. Both the device firm and pharmacy letters are covered in this post.
The 2nd half of our dive into MHRA’s published revision to their 2015 Data Integrity Guidance. Changes are abundant when we compare the 2015 and 2018 versions. We share (in a clear table format) the final 23 updates along with our GMP expert’s conclusions.
MHRA published a revision to their 2015 Data Integrity Guidance. The 2018 revision, in general, provides more detail and granularity than the 2015 version. Several items from the 2015 version are absent from the 2018 version. However, some items are more detailed in the 2018 version. We address all within this post and identify the nature of the addition, deletion, or revision.
This week the FDA published 4 warning letters (3 to seafood companies and 1 to an API manufacturer - Les Produits Chimiques B.G.R. Inc). We cover the latter below.
“I can’t promise success, but I can tell you I’ve been successful most of the time when I walk a scientist through their process. To that end, I make the following proposal, which I hope will start a conversation here and which can be continued with your company and with your service providers.”
While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted. Last year, the FDA made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs. This post dives deep into this model – including new timelines for those of us in the drug industry.
The FDA posted 9 warning letters this week including 1 to a device manufacturer, 1 each to an API manufacturer and compounding pharmacy, and, finally, 2 to finished dosage form manufacturers.