Inspections, Compliance, Enforcement, and Criminal Investigations
The ORA Medical Device Industry Initiatives program encompasses preannounced medical device inspections, FDA 483 Annotation and Postinspectional Notification.
The instructions for Preannouncement (including the criteria to be used in determining when preannouncement is appropriate), FDA 483 Annotation and Post-inspection Notification were provided in an April 3, 1996, Federal Register Notice (Volume 61, Number 65). Refer to the Investigations Operations Manual (IOM) for further information.
When contacting the firm for the preannounced QSIT Inspection, the investigator should ask for a copy of the firm's Quality Policy and high level Quality System Procedures (including Management Review Procedures), Quality Manual, Quality Plan or equivalent documents to preview prior to the inspection. The firm is not required to supply these documents. The investigator should tell the firm that the preview of these procedural documents would facilitate the inspection. The documents would be returned at the time of the inspection. If you find deficiencies in these documents, you should request copies of the original documents after you initiate the inspection.