This week, one warning letter was issued by CDER to a finished pharmaceutical manufacturer, and another was issued to a Genetech site that manufactures human cells/tissue-based products.
FDA posted four warning letters this week including one to an API manufacturer, one to a compounding pharmacy and one to a drug product manufacturer.
We compiled last week's warning letters for you. Take a look.
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.
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.
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.