From finding "live raccoons, live cats, and a dead possum" at a drug retailer to possible microbial contamination, here are last week’s recalls.
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.
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.
FDA posted 10 warning letters this week: 8 of them citing unapproved or misbranded new drugs with problematic websites as the source of FDA’s information. Along with this, 1 warning letter was published that was issued to a compounding pharmacy.
We took a snapshot of the 7 warning letters the FDA sent to food companies last month. Food violations ranged from failing to exclude rodents from site to failing to have an HACCP plan.
It’s violation study time, and our GMP expert has extracted the key documents from this week's global headlines. To note is Operation Pangea XI as well as Europe's multiple reports of GMP non-compliance.
In the past week, we added the following 37 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store.
FDA posted 6 warning letters this week. Among the ones we cover are 1 issued to a pharmaceutical company in South Korea and 1 issued to a clinical trial investigator in California.
What does it even mean to officially respond to a 483 and, better yet, how can a 483 be avoided altogether? The answer is basically split into 3 parts that we dive into in this post.