Is Raw FDA Data Skewing Your Analyses?

Which GMP quality system was most often linked to FDA drug recalls since 2012?  Redica’s Jerry

Should ICH Tackle Standard Development for CGT Products?

Cell and Gene Therapy (CGT) is one of the fastest-growing areas of research and development in the

FDA on the Evolution of Biologics Inspections: Part III

How does FDA decide whether to conduct a biologics manufacturing inspection in person or perform a remote

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

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

Webinar – Quality Intelligence: from Information to Knowledge

Webinar – Comparing Inspection Observations between FDA and Health Canada

Webinar – Data Integrity and Quality Culture – Enabling far more than “just” compliance

Report – Analysis of FDA 483s Issued to Excipient Manufacturers Since 2000

Report – Analysis of FDA Drug GMP Warning Letters for FY2022

Report – Breaking News: The First FDA Warning Letter to an Excipient Manufacturer

Assessment – Investigator Snapshot

Assessment – Site Snapshot