Resources

FDA posted 7 warning letters this week including: 2 warning letters to Medtronic regarding non-conformance that resulted in Class I recall of a defibrillator earlier in 20181 firm in Canada1 firm in China Also, this week the “U.S. Food and Drug Administration today announced a series of critical and historic enforcement actions related to the […]

1. Select an ePRO provider who can support the Primary Investigator’s access to source data. To help you choose a provider, ask: What happens to your subjects’ diary data?Does it disappear from the device, evaporating into the cloud hosted by your ePRO provider?Is your provider’s solution to print “copies” of the device data at the […]

In the past 2 weeks, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Can’t find the 483 you’re looking for? Here’s a FREE company report instead. [supsystic-tables id=20] Like this & want more? Sign up to […]

I hope to see you at the 27th Annual PDA/FDA Joint Regulatory Conference in Washington, DC from September 24th-26th. This is one my favorite conferences for a few reasons: We’ve been going to this conference for several years in a row, and we keep coming back to spend more time with our customers. Every day […]

A few months ago, I experienced one of the proudest moments of my tenure as a founder of FDAzilla… My family and I had been living in Kenya for the last 3 years (it’s a long story). Sufficed to say, we fell in love with the country and her people. We met so many courageous, […]

The FDA posted 13 new warning letters this week including: 7 issued by the Center for Tobacco Products1 to a device firm1 to a compounding pharmacy4 warning letters regarding 21 websites illegally marketing unapproved and misbranded versions of opioids including tramadol.FDA issued a press release addressing these actions. All four warning letters note that “Offering […]

Last month’s GMP Regulatory Intelligence Newsletter scans consisted mostly of just the bare essentials since I’ve been on vacation in Washington state doing a LOT of wonderful hiking with very little connectivity. This month will be back to normal…without the stunning scenery and hiking. Happy Reading, Barbara To access the latest scans discussed here, please […]

In the past 2 weeks we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Can’t find the 483 you’re looking for? Here’s a FREE company report instead. [supsystic-tables id=19] Like this & want more? Sign up to […]

The FDA posted 4 warning letters this week — 2 of which were GMP letters to drug firms. One firm manufactures APIs and the other manufactures finished pharmaceuticals. We address both below. DRUGS: Kyowa Hakko Bio Co., Ltd (Yamaguchi, Japan) received a warning letter on August 10th 2018 based on the outcome of an inspection […]

Continued from Part 1… CHANGES, REVISIONS, and DELETIONS from the 2015 VERSION: “ADDITIONS” are those sections that are new in 2018.“REVISIONS” generally denote expansion of sections between the 2 versions.“DELETED” identifies sections in the 2015 guidance that did not carry over to the 2018 version. CONCLUSION: The additional details and new topics identified in this […]