Provisions for recalls in a form consistent with the FDA QSR.
By clarifying the provision for recalls, it is possible to standardize them within the company.
By standardizing the rules, it is possible to smoothly respond to FDA inspections.
List of Forms
The following forms are included with your purchase.
MD-QMS-K15 Recall Provision
Table of Contents
3 Definition of terms
4 Basic Principle
5 Responsibilities and Authorities
6 Judgement of the Necessity of Recall and Identification of Recall Range
6.1 Judgement of the Necessity of Recall
6.2 Identification of Recall Range
7 Judgement of recall class
8 Procedure of Recall
8.1 Instruction of recall
8.2 Contact of Recall to Medical Institution and Client
8.3 Instruction to Manufacturers
8.4 Recall Actions
9 Report to Regulatory Authority (In Japan)
9.1 Start Recall
9.2 Report of Recall Process
9.3 Submit Recall Report
10 Recall in the U.S.
10.1 Identification of Delivery Destination about Exporting Products to the U.S.
10.2 Report to FDA
10.3 Recall Method and Implementation
11 Announcement to News Media
12 Storage and Disposal of Recall Products
13 Cause Investigation
14 Instruction of Improvement Actions and Confirmation of Improvement condition