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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…
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…
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…
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