Week of October 8th 2018 | FDA Sent These Warning Letters to Device Companies
FDA posted 6 warning letters this week. One to a device manufacturer which we cover. And 1 for seafood HACCP, 1 for food preparation, and 3 for tobacco.
How the FDA and the 483 Have Changed
We asked our GMP Editor in Chief 3 important questions and got 3 insightful answers. Using decades worth of professional experience, she shares both the strengths and weaknesses of this thing we call the 483.
Week of September 30th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
The FDA posted 13 warning letters this week. A collection were from the Center for Tobacco Products. There was 1 warning letter issued to a PET firm, 1 to a device firm, and 1 to a compounding pharmacy. We cover all 3 in this post.
Week of September 23rd 2018 | FDA Sent These Warning Letters to Pharma Companies
FDA posted 6 warning letters on the website this week. Among the group was 1 letter issued to a compounding pharmacy and 1 issued to a finished drug facility. We address both in this post.
Just Issued Recalls, 483s, Laws, & Warning Letters | September 2018
An efficient synthesis of all things FDA/GMP related for the entire month of September 2018. Warning letters, a refusal of an inspection, new guidance, etc. See the complete run down here.
Week of September 16th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
FDA published a total of 12 warning letters this week including: 2 to compounding pharmacies, 1 to an API manufacturer, 2 to finished drug manufacturers, and 1 to a device manufacturer. This post highlights key violations and includes links to all warning letters.
FDA Sent These 2 Warning Letters for Food Companies | August 2018
We took a snapshot of the 2 warning letters the FDA sent to food companies last month. Food violations ranged from illegally selling an animal for slaughter to selling new "drugs" without FDA approval.
Week of September 9th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
FDA posted 7 warning letters this week including 2 warning letters to Medtronic regarding non-conformance that resulted in a Class I recall of a defibrillator earlier in 2018. In addition, warning letters were issued to 1 firm in Canada and 1 firm in China. And, in the largest coordinated enforcement effort in the FDA’s history, 1,300 warning letters were issued to a single industry.
Week of August 26th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
The FDA posted 13 new warning letters this week including 7 issued by the Center for Tobacco Products, 1 to a device firm, and 1 to a compounding pharmacy. Four warning letters regarding 21 websites illegally marketing unapproved and misbranded versions of opioids including tramadol. Both the device firm and pharmacy letters are covered in this post.