34 New FDA 483s Added | November 19th 2018
In the past week, we added 34 483s to our database of 27,500+ FDA inspection documents.
Week of November 4th 2018 | FDA Sent These Warning Letters to Pharma Companies
This was an exceptionally light week of only 2 published warning letters, 1 of which was a compounding pharmacy which we cover in this post.
FINAL Part 2: How to Stop the Data Integrity Excuses
“It’s an approved device!” “Our raw data are paper.” Data integrity excuses that get the best of us confused. In the finale of this 2-post series, we cover counters to these common objections plus share a helpful MHRA resource.
9 New Recalls | Week of November 14th 2018
From finding "live raccoons, live cats, and a dead possum" at a drug retailer to possible microbial contamination, here are last week’s recalls.
49 New FDA 483s Added | November 12th 2018
In the past week, we added 49 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store.
Week of October 28th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
FDA published 13 warning letters this week. Four were sent to device firms located outside the US, and 1 was sent to a compounding pharmacy. We address these in this post along with a GCP untitled letter.
Part 1: How to Stop the Data Integrity Excuses
“Where is THAT written?” “It’s an approved device.” “It has a CE mark.” “Our raw data are paper.” Data integrity excuses we’ve all heard before. In this 2-post series, we cover counters to these common objections.
Just Issued Recalls, 483s, Laws, & Warning Letters | October 2018
An efficient synthesis of all things FDA/GMP related for the entire month of October 2018. Warning letters, refusals of inspections, new guidance, etc. See the complete run down here.
30 New FDA 483s Added | November 5th 2018
In the past week, we added 30 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store.