Conference Spotlight
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
How “Inevitable” Data Integrity Issues Cause Havoc: Part II
Insights from Peter Baker at the 46th International GMP Conference An investigation into data integrity
FDA on the Evolution of Biologics Inspections: Part II
What are the current and future anticipated states of biologics inspections regulated by CDER? At the
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