483
Solevy Co. LLCFDA 483 - Solevy Co. LLC - February 12, 2024
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Record Details
Solevy Co. LLC, a Class II medical device manufacturer in Valencia, CA, was cited for two observations during an FDA inspection. The firm failed to establish unique device identifier (UDI) labeling requirements for its personal lubricant products. Additionally, design review results were not properly documented in the design history file, indicating deficiencies in quality system compliance.
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ID · 8702522b-5508-4ae4-ac6c-5f010362e4df