While on inspection at a pharmaceutical plant site in the United States, FDA finds critical failures that impact product quality and safety. The agency finds many violations related to the Quality System, such as having no evidence of employee training, no batch records for manufactured product, missing laboratory data, and no failure investigation reports for manufacturing failures. What would be the likely outcome of this inspection? (Select one)

Question

While on inspection at a pharmaceutical plant site in the United States, FDA finds critical failures that impact product quality and safety. The agency finds many violations related to the Quality System, such as having no evidence of employee training, no batch records for manufactured product, missing laboratory data, and no failure investigation reports for manufacturing failures.  What would be the likely outcome of this inspection?  (Select one)

Answer

VAI: Voluntarily Action Indicated - FDA would issue 483 findings for the company to voluntarily resolve. FDA would check these corrections during the next inspection.

Answer

OAI: Official Action Indicated - FDA would issue a warning letter, since they would not trust that the company would voluntarily make the corrections needed.

Answer

NAI: No Action Indicated - no action would be required from the company

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While on inspection at a pharmaceutical plant site in the United States, FDA fin...

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