RECENT POSTS

Peter Baker - Right Environment
Post by Peter Baker | July 18, 2019

MHRA’s “Right Environment”

Former FDA Investigator Peter Baker gives insight to MHRA's GXP guide for data integrity.

WWL071619
Post by Barbara W. Unger | July 16, 2019

Week of July 7th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

There were six warning letter postings during this week, including one regarding Akorn's site in Somerset, NJ that the company announced a few weeks ago.

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Post by Barbara W. Unger | July 11, 2019

Analysis of CDER Office of Pharmaceutical Quality Report on the State of Pharmaceutical Quality

GMP expert Barbara W. Unger provides her assessment of CDER's State of Pharmaceutical Quality Report.

WWL070919
Post by Barbara W. Unger | July 9, 2019

Week of June 30th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

A surprisingly busy week for enforcement considering the federal holiday.  Warning letter enforcement includes five drug warning letters published this week, two of which were sent to API re-packagers, and one to a compounding pharmacy.

WWL070319
Post by Barbara W. Unger | July 3, 2019

Week of June 23rd, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Three warning letters were posted this week: two for drugs and one for device GMP violations. Akorn also announced that they received a warning letter but it has not yet been published.

KENX Blog Header
Post by FDAzilla | July 2, 2019

Govzilla Speaking at KENX’s GMP University

When it comes to data integrity, audit recommendations, and corrective actions, the correct data analysis is essential for making informed, impactful decisions.

Post by FDAzilla | June 28, 2019

Access FDAzilla PRO for FREE!

We are excited to announce that we now offer a free version of our FDAzilla PRO platform!

Mindfulness/DI
Post by Julie Maurhoff | June 27, 2019

How Mindful Leadership Supports Data Integrity

Can mindfulness influence data integrity? Discover the insights Julie Maurhoff, a Senior Director of GxP Compliance and Inspection Readiness at Ultragenyx Pharmaceutical, gained after researching the topic.

WWL062519
Post by Barbara W. Unger | June 25, 2019

Week of June 17th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Unlike last week, warning letter enforcement is sparse this week with only one drug GMP warning letter, none to compounding pharmacies and none to device firms.