SBS - The best value in QMS software

FDA Inspection Guide to MD - New Web Portal for Inspectional Database

sreenu927

Quite Involved in Discussions
#1
Hi All,

1. I think many of you might have aware of the new release of FDA Inspection Guide to Medical Device Manufacturers.

Who are not aware, have the attachment.

2. FDA warning letters: analysis of quality system data, as attached.

3. FDA to make enforcement and compliance activities accessible online
New Web portal to include searchable database


Below is the url link from FDA website related to FDA initiatives to have the transparency on inspections (Form 483 (List of Observations), Sites Inspected (Inspections database) ) and so much information available.

This is very useful!!

http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm254426.htm

Regards,
Sreenu
 

Attachments

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
F FDA-registration and inspection cost 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Loss of a Quality Record - FDA Inspection Records and Data - Quality, Legal and Other Evidence 4
D FDA QSR task checklist based on inspection citations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L Email Review during FDA Inspection 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R FDA Inspection (Audit) Readiness Procedure General Auditing Discussions 14
S Do you use audio-visual streaming during FDA inspection? US Food and Drug Administration (FDA) 3
J Manufacturing CRL - Class 1 or Class 2 Inspection (FDA form 483) US Food and Drug Administration (FDA) 1
P FDA On-Site Inspection - Raw Material Manufacturing (Medical Devices) Other US Medical Device Regulations 5
somashekar Pre-Announced FDA 4 Day Inspection, Class 2 Devices, Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
M Has anyone had their electronic system scrutinized in an FDA inspection? Records and Data - Quality, Legal and Other Evidence 16
T Inspection Form Review And Approval - FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
Y FDA's Inspection Frequency for Foreign Manufacturer Other US Medical Device Regulations 1
S How soon do you get EIR after the FDA Inspection is done? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R IEC 62304 was brought up during an FDA Inspection/Audit IEC 62304 - Medical Device Software Life Cycle Processes 6
L FDA Inspection of Clean Room Processes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
P FDA QSR Inspection Consultant Recommendations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
A FDA's Medical Device Inspection related Documents 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T How to Prepare for an FDA Inspection US Food and Drug Administration (FDA) 23
AnaMariaVR2 FDA Puts Japanese Manufacturer on Import Alert after Disastrous Inspection US Food and Drug Administration (FDA) 1
J FDA Routine Inspection Pre-Anouncement - What will be checked? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
A What to do Before and After an FDA Inspection 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 25
F Obtaining copies of FDA Establishment Inspection Report US Food and Drug Administration (FDA) 8
W FDA Preapproval Inspection - Submitting a 505b2 for a combination product to the FDA Other US Medical Device Regulations 5
A FDA Inspection Preparation Hints 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R FDA Inspection - Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B FDA PAI (Pre-Approval Inspection) Readiness Check List Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
E Post Inspection Regulatory Action by US FDA - 21 CFR 803 - MDR Reporting Other US Medical Device Regulations 4
W Pre-Announcement of FDA Field Inspection - Asian manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
bio_subbu FDA Re-Inspection User Fees for Non compliant Manufacturers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
C Will FDA check the 510(k) files in field inspection? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
T FDA to Charge Industry for Food Safety - Increased Inspection Food Safety - ISO 22000, HACCP (21 CFR 120) 6
D Can an external ISO Auditor view FDA inspection results General Auditing Discussions 9
A FDA Compliance Manual, Inspection of Medical Device Manufacturers, Available ISO 13485:2016 - Medical Device Quality Management Systems 2
R Rubber Initial & Inspection Stamps - Valid or a violation of FDA quality guidelines? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
M Inspection Results - The FDA's interpretation of recording inspection results Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
J Preparing for initial FDA inspection - What must I do? ISO 13485:2016 - Medical Device Quality Management Systems 7
B What to do once an FDA Inspection is over - Seeking FDA site Link ISO 13485:2016 - Medical Device Quality Management Systems 7
G Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 7
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
E FDA 513(g) Cover Letter US Food and Drug Administration (FDA) 5
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 4
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 4
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0

Similar threads

Top Bottom