FDAzilla GMP Regulatory Intelligence Newsletter

FDAzilla GMP Regulatory Intelligence Newsletter
FDAzilla GMP Regulatory Intelligence Newsletter2019-01-24T16:12:39+00:00

Latest Issue

WEEKLY SCAN | June 10, 2019

We had an unusually busy week of enforcement with seven drug GMP warning letters and one device warning letter.  We have two forms 483 from recent inspections of firms in India, one 15 pages long, the other 23 pages long.  Both of these forms 483 have data integrity deficiencies and are worth reading in their totality.  Nothing novel in enforcement, just problems with basic GMP compliance.  Interestingly, there were no drug recalls posted this week, and only a handful [...]

By |June 17th, 2019|Categories: Weekly Scans|0 Comments

Special Reports

July 16th, 2018|0 Comments

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

June 4th, 2018|0 Comments

The U.S. Food and Drug Administration (FDA) identified failures in data governance and data integrity starting approximately 20 years ago. [...]

  • FDA17 Enforcement Analytics Summary

June 4th, 2018|0 Comments

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

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