FDA on the Evolution of Biologics Inspections: Part I
During the recent pandemic, conducting in-person biologics manufacturing facility inspections has been a
The Evolving Clinical Trial Ecosystem
New and Hybrid Clinical Trial Approaches Under Review Companies and physicians planning and executing
Persistent Non-Compliance Leads to a Consent Decree
Persistent: (adj): existing for a long or longer than usual time or continuously Non-compliance (noun):
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: 11/22/2020 & 12/1/2020
The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter
Trends & Analysis
PAIs and 483 Issuance Risk: The Trends Are Not What They Seem
Did the pandemic reduce the 483 issuance risk from pre-approval inspections (PAIs)? That is how it
Instant Download | Analysis of 2021 U.S. FDA 483 GMP Observations
A comprehensive GMP intelligence program includes monitoring health authority enforcement actions including
Instant Download | Yes, Warehouses Must Comply with Relevant GMPs
In November 2019 FDA issued an unusual warning letter to Greenbrier International Inc (doing business as
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.