FDA On-Site Inspection - Raw Material Manufacturing (Medical Devices)

P

PMIN92618

#1
Does the FDA need to be contacted for a site visit if we are a contract manufacturer who will begin to manufacture raw materials?
We currently get raw materials from a supplier but for cost purposes our customer is interested manufacturing raw materials in house that will end up in final goods.
The raw material manufacturing site will be different to the final good assembly location.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Re: FDA on-site inspection - raw material manufacturing

Hi, I moved your post to a new thread (and another forum) because it wasn't directly related to the topic of the thread where you originally posted.

FDA never needs to be contacted for arranging on-site inspections. They initiate site inspections based on their own priorities and schedule.

From your description I don't see a reason why FDA would need to inspect your site immediately. Nevertheless, they will likely review the change in your next scheduled inspection, or as a follow up to an inspection of your client.

Of course if something will go seriously wrong with the subject device(s), you can expect to see them around...

Cheers,
Ronen.
 
Last edited:

Ajit Basrur

Staff member
Admin
#3
Re: FDA on-site inspection - raw material manufacturing

Does the FDA need to be contacted for a site visit if we are a contract manufacturer who will begin to manufacture raw materials?
We currently get raw materials from a supplier but for cost purposes our customer is interested manufacturing raw materials in house that will end up in final goods.
The raw material manufacturing site will be different to the final good assembly location.
I am not sure what the "raw material" is but if there is any Drug Master File associated with the raw material (for example, resins or colorants in the form of a DMF Type III), you will have to revise the DMF to reflect the changed location.

Please provide additional information.
 
P

PMIN92618

#4
Re: FDA on-site inspection - raw material manufacturing

Thanks Ronen and Ajit.
The raw material is silicone, we will be manufacturing diaphragms (injection molding). The Injection Molding facility will be different to the address FDA has listed as our contract manufacturing site. Does the FDA need to be notified because of the additional location?
:confused:
 
P

PMIN92618

#5
Re: FDA on-site inspection - raw material manufacturing

Update: Spoke with FDA rep- says need to ask DICE if the raw materials need to be registered. If they do not, no worries. If they do, the relationship between the two sites will determine if the additional location needs to be registered.

Raw materials need to be registered???

I mentioned we have the medical device registered. Currently ordering raw materials that go into the making of that registered device. Now thinking to switch from ordering raw materials to making our own raw materials.

Do you know what she meant?

Waiting to hear back from DICE also...
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: FDA on-site inspection - raw material manufacturing

Honestly, this is becoming confusing...

By making "raw materials" (silicone elastomers?) do you refer to the chemical formulation of the substances that feed into the moulding machine?

I'm also confused as to by who/where exactly that raw materials will be made. Is it a sub-entity of the CM, the CM's client (the finished device owner), or a 3rd party? Client-supplied ingredients are sometimes treated differently from "normal" outsourced ingredients.

In general raw materials such as silicone elastomer reagents don't need to be registered (colorants excluded), but they do need to be controlled by the manufacturer. I dare say that if you move from outsourcing those reagents to formulating them in-house you're going to introduce a significant change to the device design. That, in turn, might have a raft of regulatory consequences, depending (among other things) on the specific device ProCode classification and the requirements / exemptions that apply. I recommend a thorough, careful review of all relevant aspects before you decide to make such a change.
 
Thread starter Similar threads Forum Replies Date
B What to do once an FDA Inspection is over - Seeking FDA site Link ISO 13485:2016 - Medical Device Quality Management Systems 7
S Sterilization Site Move - Dec 2018 FDA Guidance Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
Ajit Basrur FDA News FDA Guidance Document: Manufacturing Site Change Supplement US Food and Drug Administration (FDA) 0
N FDA - Change of Manufacturings Site to Contract Manufacturer in China 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A FDA Registration for Mulitple Site Locations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
G How do I change the Medical Device Product Code in FDA site? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
C FDA Labeling Requirements and Company Brochures and Web Site Content US Food and Drug Administration (FDA) 5
V Advantages of ISO 13485 or 9001 Certification for FDA Approved and Regulated site ISO 13485:2016 - Medical Device Quality Management Systems 3
J FDA Launches Medical Device and Radiation-Emitting Product Transparency Web site US Food and Drug Administration (FDA) 2
L FDA Manufacturing Site Requirements Other US Medical Device Regulations 4
AnaMariaVR2 Definition Test Site vs. Test Facility - FDA definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
E Finding Medical Device Listing Numbers on the USA's FDA site 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 19
H FDA Site generic Supplier Related forms help needed ISO 13485:2016 - Medical Device Quality Management Systems 2
A FDA site database search - Where to find listing for PMA and 510(k) ISO 13485:2016 - Medical Device Quality Management Systems 5
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 13
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

Similar threads

Top Bottom