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# Alpha Aesthetics Inspection QS, MDR Violations
- URL: https://www.fdaweb.com/alpha-aesthetics-inspection-qs-mdr-violations/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:27:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150807

A 7/19-8/5/21 FDA inspection at DSAART, doing business as Alpha Aesthetics, Carson City, NV, found violations of Quality System and Medical Device Reporting regulations in the firm’s manufacturing of silicone facial and body contouring implants. A recently-released 11/24/21 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dsaart-llc-dba-alpha-aesthetics-618157-11242021?ref=fdaweb.com) says the specific Quality System violations were: 

- failing to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure;
- failing to adequately maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to establish and maintain adequate procedures for implementing corrective and preventive action;
- failing to establish and maintain adequate procedures to control product that does not conform to specified requirements; and
- failing to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses and include testing of production units under actual or simulated use conditions.

The Medical Device Reporting violations were: 

- failing to submit a report to FDA no later than 30 calendar days after the day the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device the firm markets may have caused or contributed to a death or serious injury;
- failing to submit a report to FDA no later than 30 calendar days after the day the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device the firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; and
- failing to adequately develop, maintain, and implement written Medical Device Reporting procedures to establish internal systems that provide for timely transmission of complete medical device reports.

Alpha Aesthetics was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the corrections and/or corrective actions and a schedule for completing the work.