483
S&B Pharma LLCS&B Pharma LLC – FDA 483, Feb 6, 2020
Record Details
An FDA inspection of S & B Pharma, Inc. dba Alkem Laboratories in Fenton, MO, a drug manufacturer, revealed significant deficiencies in quality control and record-keeping. Observations included inadequate investigation records and corrective actions, scientifically unsound laboratory sampling plans, and a failure to conduct required annual product reviews. These issues indicate a lack of adherence to good manufacturing practices.
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ID · 7c8eca03-a9d6-4627-9021-7dda9ea19576
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