FDA 483 - DSP Skin Care LLC - September 09, 2021
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An FDA inspection of DSP Skin Care LLC, a drug repacker/relabeler in Los Angeles, CA, from September 7-9, 2021, revealed significant cGMP deficiencies. The firm lacked essential programs for stability testing, product release, quality control, and distribution, with several issues being repeat observations from a 2018 inspection. Key problems included inadequate labeling, missing batch records, and insufficient employee training, indicating a systemic failure to adhere to regulatory requirements.
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