Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments
Title:
Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments
Origin/Publisher:
FDA
Document Type:
Draft Guideline
Content:
mit 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.