Data-Driven Quality Intelligence with GMP Trends

Safeguard Product Quality and Manage Risk with Actionable Data

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483 Dashboard — FDA Inspection Intelligence

Welcome to GMP Trends: Your tool for Data-Driven Decision-Making

  1. Improve Quality Outcomes, Safeguard Patient Safety, and Increase Company Profitability
  2. Track FDA Inspection Trends with one simplified source of trusted quality intelligence
  3. Inspection trends reports, 483 database, FDA Investigator Profiles, Site Inspection Histories

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years of trending trusted compliance data

“GMP Trends is my GMP Friend for life.”

GMP Trends reader since 1980

“Reading GMP Trends at the start of my career was pivotal for my learning. Now, as a Senior Director of QA, I am so excited to share GMP Trends with my team”

Senior Director of QA

“In the 90’s, we would pass around the GMP Trends Report as soon as we received it”

Associate Director QC

“Recent 483’s keep the training program fresh and up-to-date.”

GMP Training Manager

“Simple and easy onboarding”

QA Asst. Manager

“As I moved from company to company throughout my career, I made sure we joined GMP Trends at each new facility”

VP Quality and Site Performance

“Critical tool for our gap analysis. We are proud of our progress”

QA Manager

A two-faceted system, all on one streamlined platform

Use our trends reports to support a proactive quality culture

  • Twice-Monthly Trends Report
  • Annual Report
  • Quarterly Special Topics Report

Use our data dashboard when you need answers fast

  • Site Inspection Histories
  • FDA Investigator Profiles
  • 483 Database
gmptrends.com/483-dashboard
483 Dashboard — FDA Inspection Intelligence
New Feature

The 483 Dashboard

The first tool that lets your compliance team search, filter, and benchmark FDA 483 observations across decades of inspection data — in seconds.

  • Search 40+ years of FDA inspection data
  • Filter by company, product type, or observation
  • Benchmark your facility against industry peers
  • Spot trends before they become your problem
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Inspection Trends Reports, Prepared by Our Industry Experts.

Published twice a month, our Trends Reports save time and resources effortlessly by identifying key risk-areas so you can stay informed of inspection trends with ease. They eliminate the need to throw time into reading swaths of 483’s, and our reports are 100% human-written, meaning they are as trustworthy as when they were first written in 1979. Both a risk monitoring tool and a continuous education resource, there’s a reason quality professionals have called the GMP Trends Report their secret advantage for nearly 50 years.

Twice Monthly Trends Report

Our scientists use real, relevant, and recent 483's to write the GMP Trends® Twice Monthly Report every two weeks. This report covers observations for manufacturing controls, laboratory controls, and medical device controls. Each issue features a rotating category. These rotating categories include: Sterile manufacturing controls, active pharmaceutical ingredient manufacturing controls, packaging and label controls and data integrity.

Annual Report

The GMP Trends® Annual Report is a review of FDA Inspection Observations for the previous Fiscal Year. The report includes examples of cited observations from actual Form 483s, trends of top-cited observations for Drug and Device Facilities. The Annual Report is published in the first quarter of the year.

Quarterly Special Topics Report

The GMP Trends Special Topics Quarterly Report expands on the Twice-Monthly report by focusing on one specific topic regardless of industry. Special Topic Quarterly Reports contain observations about topics including but not limited to change control, validation, and stability.

Expertise in Every Department

Manufacturing Controls

Process validation, equipment qualification and maintenance, deviations, customer complaints and training.

Sterile Manufacturing Controls

Environmental monitoring, sterilization validation, gowning procedures.

Active Pharma Ingredients

Quality, testing, manufacturing, packaging, document control.

Laboratory Controls

Method validation, calibration and preventative maintenance for instruments, sample preparation and reserve samples.

Packaging & Labeling

Label controls, label issuance, packaging verification.

Medical Device

Quality systems, performance qualification, purchasing, supplier verification and CAPA.

Biologics

Raw material controls, upstream processing, downstream processing.

Data Integrity

Audit trails, OOS investigations, non-contemporaneous records, computer system validation.

Our Story

GMP Trends has served Quality, Regulatory, and Manufacturing Professionals in pharmaceuticals and medical device production by trending 483’s and compliance data since 1979.

Read Our Story

Schedule a Demo to learn why thousands of professionals rely on GMP Trends® to keep them informed of the latest FDA Enforcement Trends!

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