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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).…
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.…
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…
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…
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,…
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