In a recent 483, a relabeler was cited for failing to have lot numbers and […]
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Experienced professionals with manufacturing, quality assurance and regulatory affairs expertise in pharmaceuticals and medical devices.
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Jamie Schleck
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Dina Kisver has operating experience as Vice President of Quality for a manufacturer of active pharmaceutical ingredients. She holds an MS degree in Quality Assurance and Regulatory Affairs from Temple University.
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A medical device firm recently received a 483 from FDA for failing to integrate their […]
Recent 483 observations make it clear that FDA expects a “Belt and Suspenders” approach when […]