Form FDA 483

NASDA and FDA Work Together to Implement the Produce Safety Rule

Scott Gottlieb summarized the latest work the FDA is doing to implement the Produce Safety Rule (mandated by FSMA) in a letter addressed to NASDA. FDA and NASDA have worked toward ensuring objectivity and consistency for produce inspections. They have also been working on alternatives to the traditional 483 inspectional observation form. See the complete run-through of this crucial letter for the food industry.

By | 2018-08-18T01:45:03+00:00 August 16th, 2018|CGMP, FDA Enforcement News, Food, Form FDA 483, FSMA|

The Easy Way to Research Your Inspector

When the FDA notifies you of an upcoming inspection, sometimes you only have minutes to prepare. You need information, and you need it fast. Most companies start with a Google search or call their colleagues to get information about their inspector. But with FDAzilla, you have more than anecdotes. You have real statistics. In this post, we will walk through an FDAzilla inspector profile — a snapshot of the inspection and citation history of one of the 4,000+ FDA inspectors in our database.

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 [...]