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

Source: https://www.keypedia.com/records/483/dsp-skin-care-llc/de8a17d9-248f-4c79-8503-c6f4509167f5

> FDA 483 for DSP Skin Care LLC on September 09, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DSP Skin Care LLC
- Inspection Date: 2021-09-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2021-09-09](https://www.keypedia.com/records/warning_letter/dsp-skin-care-llc/c864e7f0-d7ba-4760-b315-7d161c7dc7b1)
- [483 - 2023-10-12](https://www.keypedia.com/records/483/dsp-skin-care-llc/ecd650ee-b69a-43f4-a11d-ec64d8f85fc1)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Matthew R. Clabeaux](https://www.keypedia.com/people/matthew-r-clabeaux/9acc9b47-4063-4582-ac9a-983a07079495)
- [Stryker, Regulatory Affairs](https://www.keypedia.com/people/gunneet-kaur/e2823ed9-44f2-4553-8984-895ef8c7eece)

Company: https://www.keypedia.com/companies/dsp-skin-care-llc/9ac76746-889a-416b-af15-75110d15c22d

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6