Last week, the FDA issued a warning letter after a study drug was administered even though the study had been placed on clinical hold.
From children’s allergy medicine to antacid tablets containing metal particles, here are the latest recalls.
From poor water quality to a hush-up of failing test results, we cover five warning letters the FDA sent to companies this week.
This week the FDA posted 4 new warning letters. One was issued to a cell/tissue product manufacturer, 1 to a firm for failure to list, 1 to a compounding pharmacy, and 1 to a device manufacturer. We cover 3 of these in this post.
From contaminated toothpaste on the shelves to "lack of sterility" across the board, here are last week’s recalls.
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.
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.