FDA 483 | FDAZILLA BLOG

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…

By Tony Chen| 2018-10-03T22:35:29+00:00 October 3rd, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Food, Form FDA 483, Medical Devices|

New FDA 483s Video

If your job involves preparing for FDA inspections, watch this video and tell us what you think! Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence.

By Tony Chen| 2016-07-12T12:47:12+00:00 December 18th, 2012|cGMP Quality Assurance and FDA 483s, FDA Inspections, Form FDA 483|

How to Respond to a Form FDA 483

by Tony Chen Previously, we covered Form FDA 483 basics. Today, we talk about how to respond to them (and even better, how to avoid them). There are basically 3 parts: the pre-response, the response itself, and the post-response. […]