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.
From labels saying "you can take 4 pills" when it should really say "take 2" to injections with loose metal ferrules, here are last week’s recalls.
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.
A challenge with interpreting 483s that are issued to firms other than your own is that 483s don’t provide the context for what occurred during the inspection and how the issues were identified. Thus, to evaluate the seriousness of a 483 and the potential for additional enforcement action, I ask the following questions.
From microbial contamination to a pharmacist reporting blue specks on tablets where there should be none, here are last week's recalls.
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.
Okay, let’s settle this once and for all. We wrote a series of posts that will give you an industry primer for what these Form FDA 483s are, why they’re important, how to avoid them, and how to respond to them. Today, we cover the basics. Some of you pros out there know this stuff all too well…
FDA published a total of 12 warning letters this week including: 2 to compounding pharmacies, 1 to an API manufacturer, 2 to finished drug manufacturers, and 1 to a device manufacturer. This post highlights key violations and includes links to all warning letters.