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.
FDA posted 6 warning letters this week. Among the ones we cover are 1 issued to a pharmaceutical company in South Korea and 1 issued to a clinical trial investigator in California.