Week of November 25th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
Last week, the FDA issued a warning letter after a study drug was administered even though the study had been placed on clinical hold.
Week of November 18th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
From poor water quality to a hush-up of failing test results, we cover five warning letters the FDA sent to companies this week.
FDA Sent These 9 Warning Letters for Food Companies | October 2018
Cheese as “cancer protection” among other misbrandings last month. See the FDA’s warning letters for food companies in October.
Week of November 11th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
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.
Week of November 4th 2018 | FDA Sent These Warning Letters to Pharma Companies
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.
Week of October 28th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
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.
Just Issued Recalls, 483s, Laws, & Warning Letters | October 2018
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.
Week of October 21st 2018 | FDA Sent These Warning Letters to Pharma Companies
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 Sent These 7 Warning Letters for Food Companies | September 2018
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.