Warning letter

DSAART, LLC. dba Alpha Aesthetics: warning letter of Nov 24, 2021

FDA warning letter 618157 · Center for Devices and Radiological Health

Key facts

Reference number 618157
Company DSAART, LLC. dba Alpha Aesthetics
Subject CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated
Issue date Nov 24, 2021
Posted date Dec 28, 2021
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 803.50(a)(2), 820, 803.20(a)(3), 803.17(a)(3), 803.3, 803, 803.50(a)(1)
Inspection city Carson City
Inspection ZIP 89706
Inspection start date Jul 19, 2021
Letter on fda.gov fda.gov

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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