483
Consumer Product Partners, LLCConsumer Product Partners, LLC – FDA 483, Nov 7, 2022
Record Details
Vi-Jon, LLC in Smyrna, TN, a manufacturer, was inspected from October 31 to November 7, 2022. The inspection revealed significant deficiencies in the firm's quality control unit, specifically regarding the timely completion of out-of-specification investigations for stability testing and the failure to initiate investigations for out-of-specification microbiology incubator temperatures. These issues indicate a lack of adherence to established procedures and a breakdown in quality oversight.
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ID · 4bf09026-a96a-4f7c-b663-4166f65e8865
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