Special Reports 2018-04-17T15:50:06+00:00

SPECIAL REPORTS

SPECIAL REPORT: First Half of 2018 Warning Letters

July 16th, 2018|0 Comments

Warning Letters for the First Half of 2018 This article summarizes warning letter enforcement actions [...]

SPECIAL REPORT: FDA Data Integrity Enforcement Trends and Practical Mitigation Measures

June 4th, 2018|0 Comments

The U.S. Food and Drug Administration (FDA) identified failures in data governance and data integrity [...]

  • FDA17 Enforcement Analytics Summary

SPECIAL REPORT: FDA Enforcement Statistics Summary FY2017

June 4th, 2018|0 Comments

FDA Enforcement Statistics Summary, Seizures, Injunctions, Warning Letters, Total Recall Events, Total Recalled Products, Recalls

  • Integrity Guidance

SPECIAL REPORT: MHRA Data Integrity Guidance, 2015 and 2018

April 10th, 2018|0 Comments

MHRA published a revision to their 2015 Data Integrity Guidance, finalizing the draft revision published [...]

  • Data Governance and Data Integrity

SPECIAL REPORT: Drug GMP Warning Letters Data Governance and Data Integrity

March 15th, 2018|0 Comments

This Special Report represents the third year that we have published an evaluation of warning [...]

  • Inspection Observations

SPECIAL REPORT: FDA and MHRA Most Recent DFA Drug Inspection Observations

February 6th, 2018|0 Comments

A comprehensive GMP Intelligence program includes monitoring of health authority enforcement actions, including FDA forms-483, [...]

  • SPECIAL REPORT: FDA 2013 - 2017 Drug GMP Warning Letters

SPECIAL REPORT: FDA 2013 – 2017 Drug GMP Warning Letters

November 27th, 2017|0 Comments

This Special Report presents a detailed summary and trends of FY2017 FDA drug GMP warning [...]

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