Scenario (repeated from previous question): During manufacturing operations of sterile, injectable product batch 2020-A9, intended for release in the United States, you become aware that one of your filling lines has a piece of equipment that is causing micro cracks in the glass vial that holds the liquid drug. These micro cracks are only visible through magnification. You are not sure how long this failure has been occurring.

Based on the Scenario above, if you determine that product on the market has been impacted by this failure, what step is the company required to take next? (Select one)

Question

Scenario (repeated from previous question): During manufacturing operations of sterile, injectable product batch 2020-A9, intended for release in the United States, you become aware that one of your filling lines has a piece of equipment that is causing micro cracks in the glass vial that holds the liquid drug. These micro cracks are only visible through magnification. You are not sure how long this failure has been occurring.

Based on the Scenario above, if you determine that product on the market has been impacted by this failure, what step is the company required to take next? (Select one)

Answer

Offer patients a refund for their "bad" doses or at least a discount off their next purchase

Answer

Notify the FDA of this failure to begin collaboration on a strategy to mitigate risk to the public.

Answer

Call all patients who have taken a dose of the impacted product and ask how they are feeling

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Scenario (repeated from previous question): During manufacturing operations of ...

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