# FDA WARNING_LETTER - dsaart, llc.  - August 05, 2021

Source: https://www.keypedia.com/records/warning_letter/dsaart-llc/dcfd4f26-39f3-4620-ae23-a25ec5f61a94

> FDA WARNING_LETTER for dsaart, llc.  on August 05, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: dsaart, llc. 
- Inspection Date: 2021-08-05
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to a manufacturer of silicone facial and body contouring implants following an inspection from July 19 to August 5, 2021. The inspection revealed the firm's devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include:
1.  **Process Validation (21 CFR 820.75(a)):** Failure to validate sterilization, silicone curing, and packaging sealing processes. The firm's responses were inadequate, lacking validation plans and interim actions.
2.  **Complaint Files (21 CFR 820.198(a)):** Inadequate documentation of complaint details, investigation results, and justifications for not investigating. Redocumentation of complaints was deemed insufficient.
3.  **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Failure to adequately implement CAPA procedures, specifically regarding assessing the impact of process nonconformances.

## Related Officers

- [Director](https://www.keypedia.com/people/binita-s-ashar/5a2f78e1-1ad7-4bf2-b980-eb925e2c765e)
- [Program Division Director](https://www.keypedia.com/people/shari-j-shambaugh/aaea1185-eca8-41f8-bec7-d5d0024b582d)

Company: https://www.keypedia.com/companies/dsaart-llc/7dc713e6-95a4-4df7-91d8-6a9d43a7e052

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7