What common GMP gaps does FDA inspector Jane Chen identify?Inspector Jane C. Chen consistently identifies the same practical GMP gaps across food and animal-feed manufacturing and processing, including incomplete or missing hazard analyses and preventive controls, inadequate equipment design and maintenance ...Nov 24, 2025 · 13 min readfda-trends.hashnode.dev
What makes Atlas better than its competitors, and why is its AI co-pilot a standout feature?In 2025, compliance teams across the pharmaceutical, medical device, and food sectors are facing more scrutiny than ever. With over 6,000 FDA Form 483s issued in 2024 and increasing regulatory pressure, companies are seeking tools that not only track...Aug 1, 2025 · 4 min readfda-trends.hashnode.dev
What to Expect When Catherine J Laufmann Walks Into Your FacilityWhen FDA investigator Catherine J Laufmann arrives for an inspection, she brings a detailed, regulation-driven approach that focuses on critical components of your Quality Management System (QMS). Known for her rigorous evaluation of medical device m...Jul 9, 2025 · 6 min readfda-trends.hashnode.dev
What Does FDA Inspector Michael A. Charles Focus On During Site Inspections?FDA Inspector Michael A. Charles focuses on five major areas during pharmaceutical inspections: cleaning validation, process control, lab testing, microbiological control, and training. His observations reveal recurring compliance gaps that could lea...Jun 25, 2025 · 5 min readfda-trends.hashnode.dev
