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.

The Easy Way to Research the FDA Using Keyword Search

The FDAzilla database contains information on every FDA inspected site since the year 2000. All of our 483s and warning letters -- over 25,000 documents -- are retyped, and keywords are tagged + categorized. In this video demonstration, we show you how to perform a keyword search of FDA warning letters in our system. To continue, either watch the video below or continue reading.

Week of August 19th 2018 | FDA Sent These Warning Letters to Pharma Companies

The FDA posted 4 warning letters this week -- 2 of which were GMP letters to drug firms. One firm manufactures APIs and the other manufactures finished pharmaceuticals. This week we also saw 2 untitled letters posted from inspections in 2016 (yes, 2 years ago). We cover all 4 in this post.

Why Isn’t Paper the Same as Electronic?

Most of us feel comfortable with paper records. We like to think they’re the same as electronic records. But we hear rumblings from GMP inspections that FDA doesn’t always share that view. Let’s explore a simplified, hypothetical example to help you understand the importance of “content” and “meaning” and avoid an unnecessary 483.

By | 2018-08-29T16:51:54+00:00 August 29th, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Medical Devices|

Food Industry | FDA Draft Guidance on Multiple Entity Registration Requirements

Do you own a food company that rents space to conduct any part of your business? Or, alternatively, do you own a facility that you rent to a food company? If you answered yes to either of the above questions, keep reading to find out the answer to one question you might have, “Do I need to register with the FDA?”

By | 2018-08-28T14:27:02+00:00 August 28th, 2018|CGMP, FDA Enforcement News, Food, Supplier Management|