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

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 – Comparing Inspection Observations between FDA and Health Canada

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

Webinar – The Insider’s Guide to FDA Audit Readiness

Report – Analysis of FDA Drug GMP Warning Letters for FY2022

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

Report – Insights on Quality from FDA Leaders

Assessment – Investigator Snapshot

Assessment – Site Snapshot