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

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

Webinar – The Insider’s Guide to FDA Audit Readiness

Webinar – Top 10 Regulatory Surveillance Signals of Summer 2022

Report – Insights on Quality from FDA Leaders

Report – Wipe it With a Cloth? Particle Contamination Risks of Cloth Wipes

Report – 4 GMP Case Studies Including FDA Findings and Concerns

Assessment – Investigator Snapshot

Assessment – Benchmark Report

Assessment – 483 Observation Report