FDA Medical Device Inspections: QS Regulation vs QMSR Explained
The medical device industry is facing a pivotal shift as the FDA transitions from the legacy Quality System Regulation (21…
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Category: Actions
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How FDA Investigators Evaluate Quality Systems
Understanding how the FDA Evaluates Quality Systems is critical for any life sciences manufacturer. The agency utilizes a rigorous, system-based…
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US FDA Issues Warning Letter to Lucky Pacific Corp and Kamli International Co. Ltd.
On March 2, 2017, a US Food and Drug Administration (USFDA) Warning Letter was issued to seafood importers, Lucky Pacific…
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US FDA Issues Warning Letter to DeGrave Dairy for Illegal Drug Residue
On February 27, 2017, a US Food and Drug Administration (USFDA) Warning Letter was issued to the two owners of…
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Top 10 FDA 483 Observations of 2024—and How to Avoid Them in 2025
As regulatory pressures grow and the US Food and Drug FDA refines its inspection protocols, companies in the life sciences…
