Onsite Pharma FDA Inspections During COVID-19 Respect State Restrictions

As onsite pharma FDA inspections resume in earnest, the agency will use state advisory level rating

Desk Inspections, Missed Action Dates Take Place of FDA In-Person Site Visits

As the COVID-19 pandemic continues and in-person activities and travel remain restricted, FDA has been

FDA Chooses Not to Perform Virtual Inspections in Contrast with Non-U.S. Agencies

Health authorities rely on inspections of pharma manufacturing facilities as a critical element of the drug

FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer

FDA recently posted a 38-page form 483 issued to Novel Laboratories, Inc d.b.a.

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.

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

FDA FY2020 Drug Inspection Observations and Trends

A comprehensive GMP intelligence program includes monitoring health authority enforcement actions. 

An Update On 503B Outsourcing Facilities

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

Data Integrity 101: Why is it Important?

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

Webinar – Dive Into The New Enforcement Analytics

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

Webinar – Introducing the New Enforcement Analytics

Report – FDA FY2020 Drug Observations and Trends

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

Report – FY2018 Drug GMP Warning Letters

Assessment – Investigator Snapshot

Assessment – Peer Benchmark Report

Assessment – CFR Trend Report