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In certain situations, the agency may take other actions instead of, or concurrent with, a Warning Letter. For example: [3] The product is adulterated under Section 402(a)(3) or 402(a)(4) of the Act; There is a violation of cGMP; The product contains illegal pesticide residues; or; The product shows short contents, subpotency, or superpotency.
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A corrective action can also be a field correction, an action taken to correct problems with non-conforming products. [9] An example is the pharmaceutical company Avanos Medical , which in 2022 conducted a voluntary field correction after reports of 60 injuries and 23 patient deaths related to misplaced nasogastric feeding tubes while using ...
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]
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A product recall usually involves the following steps, which may differ according to local laws: [1] The business gathers information and analyses the problem. The affected products and batches, their locations within the supply chain, and probable causes of the problem are identified. Responsible authorities are informed of the issue and ...