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Our review of the inspection report prepared by the district office revealed several violations of Title 21, Code of Federal Regulations (21 CFR) Part 812 -Investigational Device Exemptions and Part 50 -- Protection of Human Subjects

Antidepressants Tricyclic antidepressants and selective serotonin reuptake inhibitors used for depression can also cause sexual dysfunction, such as lowered desire or arousal, delayed orgasm, and anejaculation