FDA 483 - DSP Skin Care LLC - September 09, 2021

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.