GUIDE TO INSPECTIONS OF
MEDICAL DEVICE MANUFACTURERS
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
B - Temporary Enforcement Moratorium
29
C - FOI and Design Controls 31
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