483
Pharmalogic New York City, LLCPharmalogic New York City, LLC – FDA 483, Jan 12, 2024
Record Details
An FDA inspection of Pharmalogic New York City, LLC, a PET manufacturer, revealed a significant deficiency in personnel training. The firm's on-site employees had not completed required training for the manufacture, testing, stability evaluation, and release of a specific NDA product. This indicates a serious lapse in quality system controls related to personnel qualifications.
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ID · caff468a-fc15-4bf1-959d-ea00171eef04
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