FDA Regulations: Guide to Inspections of Medical Device Manufacturers
FDA Regulations: Guide to Inspections of Medical Device Manufacturers
Guide to Inspections of Medical Device Manufacturers | December 1997 | 4 |
TABLE OF CONTENTS INTRODUCTION 1 GENERAL 2 PRE-INSPECTIONAL ACTIVITY 2 GMP INSPECTIONAL STRATEGY 3 Preannouncements, 483 Annotations, Post Inspectional Correspondence 3 DIRECTED DEVICE INSPECTION 3 Complaint Handling System 4 Complaint Handling Procedures 5 Determining Whether An Investigation Is Necessary 5 MDR Regulations - 21 CFR 803 6 Servicing 6 MDR-Reportable Service Reports 6 Corrective and Preventive Actions 6 Analyzing Quality Problem Information 7 Analyzing Service Records 7 Control of Nonconforming Product 8 Nonconformity Review and Disposition 8 Change Control 8 Process Validation 9 Components 11 Quality Audits 11 Design Controls 12 PMA Devices 13 Medical Device Tracking 13 COMPREHENSIVE DEVICE INSPECTION 13 General Provisions 13 Quality System Requirements 14 Personnel 15 Document Controls 15 Purchasing Controls 15 Identification and Traceability 16 Production and Process Controls 17 Production and Process Specifications 17 Reworking 17 Buildings 17 Environmental Control 17 Contamination Control 18 Personnel 18 Equipment 18 Inspection, measuring, and test equipment 19 Acceptance Activities 19 Labeling and Packaging Control 20 Handling, Storage, Distribution, and Installation 20 Records 21 Device master record 21 Device history record 21 Quality System Record 22 PRE-APPROVAL DEVICE INSPECTION 22 STERILE DEVICES 22 THE SMALL MANUFACTURER 23 WRITTEN PROCEDURES - "ESTABLISH" 23 ATTACHMENTS A - Medical Device Industry Initiative 25 |
