A company recently received this 483 observation: …..Document control procedures have not been adequately established. […]
Welcome to GMP Trends
GMP Trends® was created to provide relevant, real-time, and unbiased information related to U.S. FDA inspections. We have a proprietary process by which we obtain immediate access to all world-wide FDA inspection information on a real-time basis. We de-identify product and company information and track enforcement trends for our clients. Over our 30 years of providing this information, we have seen our readership grow to thousands of subscribers across the globe.
Our mission is to provide our clients with the knowledge necessary to be compliant with FDA’s most recent expectations thus enabling the production of the highest quality pharmaceutical and medical devices in the world.
Relevant, Real-Time Unbiased Information
Our mission is to provide our clients with the knowledge necessary to be compliant with FDA's most recent expectations thus enabling the production of the highest quality pharmaceutical and medical devices in the world.
The Bi-Monthly Trends Report
Our Bi-monthly GMP Trends Report gives our readers the most frequently cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is redacted to streamline the facts in an easily readable format.
Are your consultants listed on your approved vendor list? A company recently received this 483 […]