Get the free Form 483 - Hospira, Inc - McPHerson, KS Issued 10/24/2012 - fda

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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DI STRICT OFFICE ADDRESS AND PHONE NUMBER LATE(S) OF INSPECTION Kansas City District Office 8050 Marshall Drive Suite 205 Lenexa,

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What is form 483 - Hospira?

Form 483 is a document issued by the U.S. Food and Drug Administration (FDA) upon completion of an inspection, indicating any observed deviations from the current Good Manufacturing Practices (cGMP) regulations for pharmaceutical products. Hospira is a pharmaceutical company that may be subject to such inspections.

Who is required to file form 483 - Hospira?

Form 483 is issued by the FDA to the pharmaceutical company, such as Hospira, which is being inspected and found to have deviations from cGMP regulations.

How to fill out form 483 - Hospira?

Form 483 is not filled out by the company being inspected. It is filled out by FDA inspectors during the inspection process, outlining the observed deviations from cGMP regulations.

What is the purpose of form 483 - Hospira?

The purpose of form 483 is to notify the pharmaceutical company, like Hospira, of any observed deviations from cGMP regulations during FDA inspections, allowing the company an opportunity to make corrections and improvements.

What information must be reported on form 483 - Hospira?

Form 483 includes information about the observed deviations from cGMP regulations during FDA inspections. It may include details about specific processes, equipment, documentation, or systems that need improvement.

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