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Example 8 Inadequate product labeling to help adverse events reporting (WL no./date: 613792 - 10/15/2021) In up inspection, the FDA investigator noticed that the products HCG (LYO) 12,000 IU Injectable, testosterone Cypionate in GSO (5ml) 200mg/ml Injectable, FSH (LYO) 1,500 IU Injectable, and Menotropins (HMG)(LYO) 500 IU Injectable, did not include adequate information on the container to facilitate adverse event reporting