Food Blog

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Food Blog 2018-08-03T10:24:27+00:00

FOOD BLOG

FDA Warning Letters, Inspection Preparation, FSMA, More

  • New FDA 483s

41 New FDA 483s Added | October 22nd 2018

October 22nd, 2018|Biopharma / Pharma, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

In the past week, we added the following 41 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store.

  • Changes in the FDA

How the FDA and the 483 Have Changed

October 18th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, Food, Form FDA 483, Medical Devices|

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.

  • New FDA 483s

20 New FDA 483s Added | October 15th 2018

October 15th, 2018|Biopharma / Pharma, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

In the past week, we added the following 20 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store.

6 Features to Look for in FDA 483s

A challenge with interpreting 483s that are issued to firms other than your own is that 483s don’t provide the context for what occurred during the inspection and how the issues were identified. Thus, to evaluate the seriousness of a 483 and the potential for additional enforcement action, I ask the following questions.

October 11th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Inspections, FDAzilla, Food, Form FDA 483, Medical Devices|

What’s the Big Deal with Form FDA 483s?

Okay, let’s settle this once and for all. We wrote a series of posts that will give you an industry primer for what these Form FDA 483s are, why they’re important, how to avoid them, and how to respond to them. Today, we cover the basics. Some of you pros out there know this stuff all too well…

October 3rd, 2018|Categories: Biopharma / Pharma, CGMP, FDA Inspections, Food, Form FDA 483, Medical Devices|Tags: , , |