Form FDA 483

Follow the Trail to Find Data Integrity Problems

How Do I Follow The Trail? One of the most effective audits I ever participated in started with a systems-naive auditor asking a simple question: “Imagine I’m a sample arriving at your loading dock. What happens to me?” We proceeded down the trail together, following the sample through the processes of accessioning, analysis, reporting, and storage. While you can start [...]

See You At IFT

Next week we will be joining the 23,000 attendees and 1,200 other exhibitors at IFT in Chicago. We’ve made huge improvements to our platform specifically tailored to the food industry and will be sharing the latest updates. Be sure to stop by our booth to say hello and get your free supplier assessment. (RELATED: Shine a light on your [...]

84 New FDA 483s | July 9th 2018

In the past 3 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

Who Can See Form FDA 483s, and Where Do I Get Them?

Form FDA 483s are central to anyone’s FDA inspection preparation program. As the keeper of the world’s largest database of FDA 483s, we often get asked, “How do you get a hold of actual 483 reports and who else can see them?” This is where things get a little tricky. Theoretically, Form FDA 483s are public information and, thus, [...]

By | 2018-07-05T16:26:50+00:00 July 5th, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Form FDA 483, Medical Devices|

How to Monitor and Benchmark Your CMOs/Suppliers

Today I’d like to show you how to do supplier monitoring and benchmarking using FDAzilla Enforcement Analytics. We’ll start with a simple example of API manufacturers located outside of the United States. You can either watch this video to see how we do this or continue reading below. [NOTE: Don't have access to FDAzilla Enforcement Analytics? Get your personalized [...]

How to Do A Keyword Search in FDA Warning Letters

Want to learn how to do a keyword search in FDA warning letters? Watch the video or read the post below. We have about 15,000 warning letters in our database. You can search on any term or combination of terms in any of these documents. As an example, I’m going to search for “media fills”...

86 New FDA 483s | June 18th 2018

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

FINAL Part 3: The FDA and MHRA’s Most Recent Drug Inspection Observations

Continued from Part 1 and Part 2... MHRA Inspection Deficiencies I won’t reproduce the graphics from the MHRA slide deck; do read those because they contain a wealth of information at a granular level. Figure 3A shows the distribution of deficiencies among the 3 classifications by actual number for 2015 and 2016. Figure 3B shows this distribution of deficiencies among [...]

Part 2: The FDA and MHRA’s Most Recent Drug Inspection Observations

Continued from Part 1... FDA 483 INSPECTION OBSERVATIONS: It all starts with Table 1... Table 1 shows the fifteen (15) most frequent inspection observation citations (the tabulation on the FDA website shows all). Table 1 presents data in the order of those observations with the highest to lowest number for 2017, modified as described in the ‘Introduction’ section of [...]