483
PR Personal Care LaboratoriesFDA 483 - PR Personal Care Laboratories - January 29, 2024
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Record Details
PR Personal Care Laboratories in Valencia, CA, a Class II medical device manufacturer of personal lubricant, received three observations during an FDA inspection. The firm was cited for failing to establish procedures for complaint handling, control and disposition of nonconforming products, and adequate equipment maintenance schedules. These deficiencies indicate significant gaps in their quality system.
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ID · 1dd7fdd0-55c5-4275-b1fc-7b8d598edbdf