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Product Type: Sterile
Facility Type: API
Geo Asia Pacific
Enforcement Topic: Media Fills

See the whole GCP picture with our actionable data intelligence.

We’ll help you search, analyze, and derive valuable insight from thousands of CFR citations, 483s, and warning letters covering all GCP, GLP, and GVP areas.

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Product Type: Sterile
Facility Type: API
Geo Asia Pacific
Enforcement Topic: Media Fills

An intelligence tool tailored for GCP and GLP

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Insights on Clinical
Quality

Enforcement
FDA Cites Part 11 in Clinical Trial
Jamie Colgin
January 2, 2019
Trends & Analysis
How are Medical Device Trials Different?
Rebecca Stauffer
September 23, 2020
Conference Spotlight
89 Products Filed as NDAs Now BLAs Under Regulation Change
Jerry Chapman
December 16, 2020

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Redica Systems Enforcement Analytics

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Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented on Tuesday, March 30, 2021
by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

Download the slide deck and video of this informative 1-hour webinar on the common challenges small pharma firms face when developing a QMS.

What you will learn:

  • Common challenges small pharma firms face when developing a QMS
  • Recent enforcement trends involving the Quality Unit
  • Impact of the COVID-19 pandemic

Download the Special Report

APAC ad

In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

Download the Special Report

An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

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SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.

WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject

SITES Quickly assess inspection records including dates and inspectors across all of your sites

INSPECTIONS Complete list of FDA inspections by date, company, category, and country

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Discover the power of the most comprehensive database of 483s in existence.

Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.

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