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Featured Resources

Assessments

Assessment – 483 Observation Report

redica November 3, 2019
Blog
Our Top 5 Articles of 2020
redica December 29, 2020
Blog
New Year, New Enforcement Analytics
redica January 7, 2021
Conference Spotlight
FDA OMQ Regulatory Actions Increase Dramatically in FY2020
Jerry Chapman January 5, 2021
Conference Spotlight
2020 FDA Combination Products Policy and Guidance Changes

Combination products—combinations of drugs, biologics, or devices that are physically, chemically, or

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FDA OMQ Regulatory Actions Increase Dramatically in FY2020

While the number of drug GMP warning letters declined by about 30% in FY2019, the number of import

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Ashley Boam on FDA’s Proposed Quality Maturity Model

FDA is proposing the use of a model that would measure and rate the maturity of a pharma company

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Enforcement
OTC Skincare Firm Receives Warning Letter Due to CGMP Concerns

December is generally a slow time when it comes to posting of FDA Warning Letters. Nevertheless, on Dec.

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FDA Warning Letters Weeks of 11/22/2020 & 12/1/2020: Water Leaks, Misleading Statements, & Adulteration

The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter

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FDA Warning Letters Week Of 11/8/2020: Unapproved Cord Blood Product & No Process Validation

Of the two drug-related FDA Warning Letters issued last week, one, issued to a homeopathic drug

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Trends & Analysis
How to Identify Data Integrity (and Other) Trends

Why should firms review regulatory noncompliance data?  What useful information can be gained via

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An Update On 503B Outsourcing Facilities

In response to the 2012 fungal meningitis outbreak that occurred at the New England Compounding Center

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Data Integrity 101: Why is it Important?

In recent years, significant data integrity lapses have occurred at global pharmaceutical, biotechnology,

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Webinars
Webinar – General Announcement Campaign – P

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Webinar – The Ecosystem for Smart Combination Products: What About Regulations

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Webinar – Introducing the New Enforcement Analytics

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Reports
Report – Special Report from the FDLI Enforcement, Litigation, and Compliance Conference

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Report – FY2018 Drug GMP Warning Letters

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Report – State of Pharmaceutical Quality

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Assessments
Assessment – Investigator Snapshot

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Assessment – Peer Benchmark Report

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Assessment – CFR Trend Report

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Insights

Hosting a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase

In Part 4 of our series on virtual agency inspections, former FDA investigator Ricki Chase provides her advice on how to host a virtual inspection, including best practices, how to adjust your logistics, and how to prepare for a closeout meeting.

Jerry Chapman July 23, 2020

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