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.
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.
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.
An efficient synthesis of all things FDA/GMP related for the entire month of September 2018. Warning letters, a refusal of an inspection, new guidance, etc. See the complete run down here.
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.
It's 483 study time, and our GMP expert has extracted the key points in this week's featured 483 posted by the FDA. Violations ranged from failing to provide scientific reasons for invalidating OOS results to failing to prevent colored residues on equipment.
We took a snapshot of the 2 warning letters the FDA sent to food companies last month. Food violations ranged from illegally selling an animal for slaughter to selling new "drugs" without FDA approval.