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The medical device industry is facing a pivotal shift as the FDA transitions from the legacy Quality System Regulation (21 CFR 820) to the new Quality Management System Regulation (QMSR). This comprehensive guide explains the core differences, the alignment with ISO 13485:2016, and what manufacturers must prioritize to ensure a successful FDA QMSR inspection outcome in 2026.
Understanding how the FDA Evaluates Quality Systems is critical for any life sciences manufacturer. The agency utilizes a rigorous, system-based approach to ensure that products meet safety and purity standards. This guide analyzes the six core systems of the FDA’s inspection model, including the Quality System, Production, and Laboratory Controls. Learn to identify gaps in your facility before investigators arrive, ensuring a successful audit outcome and protecting your operational license.
On March 2, 2017, a US Food and Drug Administration (USFDA) Warning Letter was issued to seafood importers, Lucky Pacific Corp and Kamli International Co. Ltd. This Warning Letter was issued for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. These violations caused the ready-to-eat dried fish snacks and ready-to-eat…
On February 27, 2017, a US Food and Drug Administration (USFDA) Warning Letter was issued to the two owners of DeGrave Dairy. This Warning Letter was issued for violations of the Federal Food, Drug, and Cosmetic Act (the Act). DeGrave Dairy is a dairy operation that the Minneapolis District inspected for three days. The violations included –Presence…
As regulatory pressures grow and the US Food and Drug FDA refines its inspection protocols, companies in the life sciences and healthcare industries must stay one step ahead. Each year, the agency releases insights from its FDA Form 483 observations—warning flags issued after inspections. In this post, we analyze the top 10 FDA 483 observations…
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