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.
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.
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.
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.
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.
FDA posted 6 warning letters this week. One to a device manufacturer which we cover. And 1 for seafood HACCP, 1 for food preparation, and 3 for tobacco.
We asked our GMP Editor in Chief 3 important questions and got 3 insightful answers. Using decades worth of professional experience, she shares both the strengths and weaknesses of this thing we call the 483.
The FDA posted 13 warning letters this week. A collection were from the Center for Tobacco Products. There was 1 warning letter issued to a PET firm, 1 to a device firm, and 1 to a compounding pharmacy. We cover all 3 in this post.
FDA posted 6 warning letters on the website this week. Among the group was 1 letter issued to a compounding pharmacy and 1 issued to a finished drug facility. We address both in this post.