SBS - The best value in QMS software

FDA Audit next week

Free Trial of DISCUS Desktop
Elsmar Forum Sponsor
M

MsMorgan

Registered
#13
#13
Doug Tropf said:
Information on Pre-announcement of Inspections can be found in the FDA's Guide to Inspections of Quality Systems.

I have also reviewed some recent 483s citing complaint handling - particularly as it applies to MDR procedures. As a contract sterilizer, we don't actually market the product, so my understanding is the MDR requirements of CFR 803 would not apply to our operation.

Thanks for the good luck wishes. This is our first FDA inspection in soon to be four years.
Click to expand...
I believe you still have to have a MDR procedure...
 
D

Doug Tropf

Quite Involved in Discussions
#15
#15
Day one of our ongoing FDA audit went as follows:

Opening meeting
Tour of facility
Review of process deviations for past year plus related corrective actions
Review of customer contracts
CAPA - forms, procedures, open and closed CAPAs for past two years

Inspectors advised at the end of day one that they had not found anything that they were concerned about. :)
 
Ajit Basrur

Ajit Basrur

Staff member
Admin
#16
#16
Doug Tropf said:
Day one of our ongoing FDA audit went as follows: .......................... Inspectors advised at the end of day one that they had not found anything that they were concerned about. :)
Click to expand...
Great Job Doug :applause:

Appreciate that you took your valuable time off to update us. :thanx:

How many more days is the inspection ?
 
D

Doug Tropf

Quite Involved in Discussions
#17
#17
During day two the FDA inspectors audited:

Alarm testing and maintenance records on our process equipment
Calibrations of our monitoring and process equipment
Random samples of our DHRs
Job descriptions

So far - so good.
 
D

Doug Tropf

Quite Involved in Discussions
#18
#18
The following items were covered during day three of our inspection:

Sterilization cycle validations - including protocols
Steam quality testing
Process software applications and validations
Training procedures and documentation
Internal audit procedures and audit schedule
Management review procedures and evidence of meetings being held
Document control procedures
Process equipment calibrations / documentation

Wrap up is tomorrow, barring something unforeseen, I think we are good.:cfingers:
 
P

Pataha

#20
#20
Excellent job.

To add to your reference library is this link Investigations Operations Manual 2007 http://www.fda.gov/ora/inspect_ref/iom/, in the past it is updated
in March.
for medical device companies Chapter 5 is the ground rules for the Auditor.

I am not sure if one should be overly concerned about this, but it appears that for your Internal Audit program and Managment Review, you provided quite a bit of information.

Under 21 CFR 820.180(c) - (c) Exceptions. This section does not apply to the reports required by 820.20(c) Management review, 820.22 Quality audits, and supplier audit reports used to meet the requirements of 820.50(a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.

So basically when this subject matter comes out you have a upper management type to sign certifying that this activities are done.

Plus, it has been my experience that the Internal Audits being done and some outputs of Managment review show up in the CAPA system.

Still not sure if this is a point of concern . Your way of handling it should have been less adversarial, then some of the encounters I have witnessed for these sections of 21 CFR 820.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A FDA and NB audit of Engineering Drawings in DHF and DMR. Medical Device and FDA Regulations and Standards News 1
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
W ERP Audit Trail audit by FDA? Regular audit trail report template? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
R FDA Inspection (Audit) Readiness Procedure General Auditing Discussions 14
Ronen E FDA encourages industry to participate in Medical Device Single Audit Program (MDSAP) Other US Medical Device Regulations 10
V Data Quality and Data Integrity - Audit Trail - Part 11 - WHO - FDA - MHRA - PDA US Food and Drug Administration (FDA) 6
M US FDA "Single Audit Program" and Brazil Other Medical Device Regulations World-Wide 3
R IEC 62304 was brought up during an FDA Inspection/Audit IEC 62304 - Medical Device Software Life Cycle Processes 6
B Is there an FDA requirement for a Supplier Audit Schedule US Food and Drug Administration (FDA) 22
A What documents would an FDA auditor want to see in an FDA Audit of Quality System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
A Can Internal Audit Observations be kept confidential from State FDA inspections ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
R Always Internal Audit all Line Items of applicable FDA Regulations? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Internal Audit Confidentiality - Exempt from review by the FDA under 820.180(c)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B FDA 21 CFR Part 820 Medical Device Audit Criteria US Food and Drug Administration (FDA) 5
Ajit Basrur FDA guidance on accepting audit reports by other auditors/regulators US Food and Drug Administration (FDA) 1
G FDA Voluntary Audit Report Submission Pilot Program now a final guidance document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
E FDA Quality Systems and DAMAS (Dental Appliance Manufacturers Audit Scheme) US Food and Drug Administration (FDA) 3
A FDA Audit Documentation - Recently released FDA Warning Letter Qualification and Validation (including 21 CFR Part 11) 9
E 483 Process Validation - FDA Audit Observation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Internal Audit Closure Certification Report - FDA Requirements US Food and Drug Administration (FDA) 5
AnaMariaVR2 Pros & Cons of FDA viewing QAU Audit Report Findings US Food and Drug Administration (FDA) 7
L FDA Audit - How much advance notice do foreign manufacturers get? ISO 13485:2016 - Medical Device Quality Management Systems 4
Q ISO 13485, FDA's QSR, CMDR, MDD: Seeking Internal Audit Correlation Matrix Various Other Specifications, Standards, and related Requirements 3
D FDA Audit - who is "eligible"? Medical Device Sub-Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
M FDA Audit Procedure - SOP - Small Medical Device Company Document Control Systems, Procedures, Forms and Templates 19
S Does anyone know if ISO publishes audit findings/results much like the FDA ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
R FDA Audit - Medical Device missing Repair Record General Auditing Discussions 21
D Upcoming FDA ISO 13485 audit guidance (draft version) ISO 13485:2016 - Medical Device Quality Management Systems 19
M Procedure on Traceability - FDA audit finding US Food and Drug Administration (FDA) 8
T FDA Medical Device Audit Checklist. Other US Medical Device Regulations 13
S FDA Part 820 Audit vs. ISO 9001 - Anything I should be aware of as an auditor? Various Other Specifications, Standards, and related Requirements 13
P Is anyone out there considering using a Third-Party for their FDA Audit? US Food and Drug Administration (FDA) 7
E FDA - Audit - Response - Observation form 483. Do we now receive a formal letter? US Food and Drug Administration (FDA) 5
D Help - FDA Audit - Caliper Calibrated .750 Use - Calibrated @ 0 & 1" General Measurement Device and Calibration Topics 7
W Rate your FDA Audit Experience ISO 13485:2016 - Medical Device Quality Management Systems 6
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5

Similar threads

Top Bottom