483
Coronado Aesthetics LLCFDA 483 - Coronado Aesthetics LLC - August 22, 2025
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Record Details
Coronado Aesthetics LLC, a class II device specification developer in Dallas, TX, received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate design validation and review procedures, a lack of management reviews, and a failure to conduct required quality audits. These issues indicate a systemic breakdown in maintaining compliance with regulatory requirements.
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ID · 48e9ca2a-2850-4e93-9726-e73bc71c90e0