SBS - The best value in QMS software

When the FDA comes a knockin

M

mlabardi

#21
#21
I was at a company a few years ago which had an unannounced for cause inspection by the FDA.

At the time the company was in the processes of closing the facility and relocating to another state. When the FDA showed up, all senior management was out of the building/state.

We immediatly called the responsible senior management and got them on a plane to come back.

We were 100% up front with the investigator and explained the situation. We asked politely if she could return the next day, she declined and indicated she would like to start her research that first day. We complied with her request and provided all the basic information, facility tour, and answered the questions we knew.

She did arrive back in our facility the next day (senior management arrived) and they completed any unanswered questions.

Luckily the inspection was short and sweet without any 483's issued.

We were fortunate that people who were in the facility the first day were very familiar with the situation and could answer most of the questions.
 
Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
Wes Bucey

Wes Bucey

Prophet of Profit
#22
#22
mlabardi said:
I was at a company a few years ago which had an unannounced for cause inspection by the FDA.

<SNIP>
Luckily the inspection was short and sweet without any 483's issued.

We were fortunate that people who were in the facility the first day were very familiar with the situation and could answer most of the questions.
Click to expand...
'nuff said? Considering the potential consequences, it makes sense to have someone with authority and responsibility "on call" to come in and answer questions for an inspector, especially when there is a pending action. Just how long an inspector is willing to sit and cool his/her heels waiting is always going to be a crap shoot.

Maybe, just maybe, an alternate solution might be to have a on-site escort and a telephone conference with the off-site authority to mollify the inspector expecting authoritative answers to questions.
 
W

Weiner Dog

Med Device Consultant
#23
#23
Working for the FDA for over 20 years, FDA does not take kindly to inspection refusals or sample collection refusals (both either partial or total refusals). If the firm is in operation, then FDA can come knocking, no matter if top management is there or not. This is not an excuse for a refusal- because the fimm is in operation! If FDA is refused (or is kept waiting for a while)(especially as a result of performing a compliance or for cause level III audit inspection or sample collection), problems will occur! Why would a firm want to have FDA with a US marshall carrying an inspection warrant visit?

Refusals, etc., just make FDA look at more records and camp out at the firm longer (especially during for cause inspections or investigations).
 
S

szohar

#24
#24
If you have SOPs, you should make "How to Respond to an Audit" one of your SOPs. That way, no matter who gets the door, that person can sit the auditor(s) in the waiting area, check the SOP, and follow the procedure.

My organization does have this as a procedure, but I'd have to ask permission to share it, so let me know if you are unable to get the information you need through any other channels.
 
Ajit Basrur

Ajit Basrur

Staff member
Admin
#25
#25
geochaz said:
Working for the FDA for over 20 years, FDA does not take kindly to inspection refusals or sample collection refusals (both either partial or total refusals). If the firm is in operation, then FDA can come knocking, no matter if top management is there or not. This is not an excuse for a refusal- because the fimm is in operation! If FDA is refused (or is kept waiting for a while)(especially as a result of performing a compliance or for cause level III audit inspection or sample collection), problems will occur! Why would a firm want to have FDA with a US marshall carrying an inspection warrant visit?

Refusals, etc., just make FDA look at more records and camp out at the firm longer (especially during for cause inspections or investigations).
Click to expand...
Welcome back Geochaz :bigwave:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
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
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 5
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 3
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
P Writing a presubmission to the FDA prior to the De novo submission US Food and Drug Administration (FDA) 4
K FDA - Can we have more than 1 Initial Importer Medical Device and FDA Regulations and Standards News 4
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 12
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
O Clarifying FDA definition of "finished device" and “capable of functioning” 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
P Choice of FDA reviewer US Food and Drug Administration (FDA) 6
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
T Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
J FDA notification of address change US Food and Drug Administration (FDA) 2
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 8
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 8
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
gunnyshore Form FDA 3500A MedWatch eSubmitter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7

Similar threads

Top Bottom