FDA 483 - Tower Laboratories Ltd. - May 02, 2019
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An FDA inspection of Tower Laboratories Ltd. in Montague, MI, a dietary supplement manufacturer, revealed a significant deficiency in their quality control processes. The firm failed to verify that their laboratory examination and testing methodologies, particularly for ingredient identification using reference standards, were appropriate for their intended use. This indicates a serious lack of scientific rationale and validation for critical quality control procedures.
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