483
Stason Pharmaceuticals, Inc.Stason Pharmaceuticals, Inc. – FDA 483, Apr 13, 2021
Record Details
An FDA inspection of Stason Pharmaceuticals, Inc. in Irvine, CA, revealed two significant observations related to quality system deficiencies. The firm was cited for inadequate employee training, specifically failing to provide follow-up training after identifying a trend of human errors. Additionally, the quality control unit lacked written procedures, particularly concerning the evaluation and assessment of an outside contract lab used for microbiological testing.
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ID · 9806ac15-ac99-4c40-948b-486265e6ae4d
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