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Tips For Responding To FDA Form 483 Inspectional Observations

Source: Vaisala, Inc.

By Bruce McDuffee, Vaisala Life Science Division

According to the FDA document, Investigations Operations Manual (IOM), the FORM FDA 483 INSPECTIONAL OBSERVATIONS is intended for use in notifying the inspected establishment’s top management, in writing, of “... significant objectionable conditions, relating to products and/or processes, or other violations of the FD&C Act and related Acts which were observed during the inspection.” This statement and other background information can be found in section 5.2.3 Reports of Observations of the IOM. The FDA goes on to point out that these reports of objectionable conditions are made based on the judgment of the inspector. As with many government inspections, the inspector has discretion in his or her interpretation of what is “significant” and what is minor. Nevertheless, the issuance of “written inspectional observations” is required by law when an inspector finds a possible deviance from federal regulations.

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