Conference Spotlight
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
Enforcement






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