A company recently received this 483 observation: ….. The responsibilities and procedures applicable to the […]
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.
GMP Trends® has been an extremely valuable tool for our company. It is widely read by most of our operational groups from Quality to Research and Development to Pharmacovigillance. Everyone eagerly awaits the latest issue! Thank you for producing such a useful, quality publication, and after almost 20 years, we look forward to another 20 years and more!
GMP Trends® has been of special value as used in seminars on Law and Regulations. Not only do they help to verify current GMP discrepancies that continue to be encountered in the relevant industries, but they do so with excerpts in the FDA-483 format. These help to provide a 'real life' aspect to the classroom scenarios.
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.
A company recently received this 483 observation: …. Laboratory records do not include complete data […]