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# 2 Observations in Venus Concept FDA-483
- URL: https://www.fdaweb.com/2-observations-in-venus-concept-fda-483/
- Published: 2021-06-23T12:00:00.000Z
- Updated: 2026-09-14T17:04:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149603

FDA has released the FDA-483 issued following a 1/13-1/16 inspection at Venus Concept, a San Jose, CA, manufacturer. The two inspection observations were: 

- failing to adequately document corrective and preventive action activities and/or results; and
- failing to adequately maintain complaint files.