483
PTI Georgia, LLCPTI Georgia, LLC – FDA 483, Feb 6, 2020
Record Details
PTT Royston LLC, a drug manufacturer in Royston, GA, was cited for multiple significant deficiencies during an FDA inspection. Observations included failures in complaint investigations, premature product release without complete testing, inadequate annual product reviews, and deficiencies in quality control unit procedures and laboratory controls. These issues indicate a lack of adherence to good manufacturing practices.
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ID · 517566fa-2ffa-4d3d-b9fe-e58a127b9e24
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