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We provide insight on the latest FDA-483 observations. Our reports are filled with the knowledge you need to stay compliant.

Welcome to GMP Trends

GMP Trends® was created to provide relevant, real-time, unbiased information derived from actual 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.

GMP Trends - FDA-483 Experts

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 #1077

December 1, 2021

Issue #1076

November 15, 2021

Stay in Compliance!

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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.

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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.

According to the Code of Federal Regulations (21 CFR 820.100 Corrective and Preventative Action), each […]

On November 15, 2021 GMP Trends® posted Issue #1076 featuring observations pertaining to data integrity […]

A company recently received the following observation: …..Written MDR procedures have not been developed, maintained […]