Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments
Titel:
Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments
Internet:
Herkunft/Verlag:
FDA
Dokumentenart:
Entwurfs-Leitlinie
Inhalt:
The purpose of this draft guidance is to explain how the owner, operator, or agent in charge of a device establishment may submit a request for nonbinding feedback to FDA regarding actions the firm has proposed to take to 111address certain kinds of inspectional observations that have been documented on an FDA Inspectional Observations Form (Form FDA 483) and issued to the firm upon completion of an inspection of the firm’s establishment.