483
Solevy Co. LLCSolevy Co. LLC – FDA 483, Feb 12, 2024
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
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