About 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 FDA inspection information on a real-time basis. Over our 30 years of providing this information to our clients, we have seen our readership grow to thousands of subscribers across the globe.

Our Mission

Our mission is to provide our clients with the knowledge necessary to be compliant with FDA's most recent cGMP expectations thus enabling the production of the highest quality pharmaceutical and medical devices in the world.

Our Editors and Advisory Team

Experienced professionals with manufacturing, quality assurance and regulatory affairs expertise in pharmaceuticals and medical devices.

Jamie is a private equity investor with operating experience leading teams in highly regulated industries including pharmaceuticals, medical devices, and aerospace.

Jamie Schleck

Investor and Adviser

Denise Thompson is Manager of Operations for GMP Trends and brings years of experience in correspondence with the Food and Drug Administration.

Denise Thompson

Manager of Operations

Dina Kisver has operating experience as Vice President of Quality for a manufacturer of active pharmaceutical ingredients. She holds an MS degree in Quality Assurance and Regulatory Affairs from Temple University.

Dina Kisver

President and Chief Editor

Join the thousands of professionals who rely on GMP Trends® to keep them informed of the latest FDA Enforcement Trends!

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 the initials […]

A company recently received this 483 observation:  …..Laboratory records are deficient in that they do […]

A company recently received this 483 observation:  ….. Equipment and utensils are not cleaned and […]