GMP Trends - FDA-483 Experts

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.

Issue #1024

September 16, 2019

Issue #1023

September 3, 2019

DPT Laboratories

August 20, 2019

Stay in Compliance!

Relevant, Real-Time, Unbiased Information.





Expertise in Every Department

Manufacturing Controls

Observations including but not limited to process validation, equipment qualification and maintenance, deviations, customer complaints and training.

Sterile Manufacturing Controls

Observations including but not limited to environmental monitoring, sterilization validation, gowning procedures.

Active Pharma Ingredients

Observations including but not limited to quality, testing, manufacturing, packaging, document control.

Laboratory Controls

Observations including but not limited to method validation, calibration and preventative maintenance for instruments, sample preparation and reserve samples.

Packaging & Labeling

Observations including but not limited to label controls, label issuance, packaging verification.

Medical Device

Observations including but not limited to quality systems, performance qualification, purchasing, supplier verification and CAPA.

Testimonials

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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:   …..Document control procedures have not been adequately established. […]

Are your consultants listed on your approved vendor list? A company recently received this 483 […]

A company recently received this 483 observation:  …..There was a failure to handle and store […]