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 poor water quality to a hush-up of failing test results, we cover five warning letters the FDA sent to companies this week.
Cheese as “cancer protection” among other misbrandings last month. See the FDA’s warning letters for food companies in October.
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.
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.
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.