483
Ajinomoto Althea, Inc.FDA 483 - Ajinomoto Althea, Inc. - March 18, 2019
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Record Details
An FDA inspection of Ajinomoto Althea, Inc. in San Diego, CA, a drug manufacturer, revealed three observations. The firm was cited for inadequate deviation investigations regarding broken vials, a lack of quality control unit oversight due to an unclear quality agreement, and a failure to perform required clean hold time studies and cleaning validation.
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ID · 278c5bc4-34fe-420e-8580-fda83cf0faf4