Aug 1, 2025 · 4 min read · 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...
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Jul 9, 2025 · 6 min read · When 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...
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Jun 25, 2025 · 5 min read · 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...
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