Regulatory Open Forum

Hello Regulatory Team Members,

I have a question regarding auditing facilities.  Since July of 2020, our company transitioned into a new company within the same organization, however, and we no longer manufacture products at our facility and all manufacturing products are done in our corporate facility in Japan. 
In past, FDA has come into our facility for auditing.  Since we are no longer producing products, is FDA still required to come in for inspections? I assume they would because we are still classified as a Class 2 medical device company. I assume this is still part of the Quality Systems requirement for a medical device company. So instead of auditing as a manufacturer, would they audit us on the quality aspect side of quality regulations? Any feedback is appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
------------------------------

FDA has the statutory authority [Section 704(a) of the FD&C Act] to enter and inspect any factory, warehouse, or establishment in which devices are manufactured, processed, packed, or held, for introduction into interstate commerce.  FDA has a very liberal interpretation of "manufacture".  A general rule is that, if the operations in which the establishment is engaged exceed the registration thresholds of 21 CFR 807.20(a), and the establishment is not GMP-exempt, then such establishment is likely to be added to (or remain in) FDA's inspection queue.  A common version of this is where the firm is a specification developer who outsources device fabrication to a third party.  Whether that third party is a sister organization under the same corporate ownership, or whether it is an independent third party, the specification developer is, pursuant to 21 CFR 820.50, required to assure proper control of the fabricator.  FDA routinely inspects specification developers, and focuses heavily on design controls and purchasing controls (among other things like CAPA and complaint handling of course).

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 22-Mar-2021 18:54
From: Vicki Ong
Subject: FDA Auditing Question

Hello Regulatory Team Members,

I have a question regarding auditing facilities.  Since July of 2020, our company transitioned into a new company within the same organization, however, and we no longer manufacture products at our facility and all manufacturing products are done in our corporate facility in Japan.
In past, FDA has come into our facility for auditing.  Since we are no longer producing products, is FDA still required to come in for inspections? I assume they would because we are still classified as a Class 2 medical device company. I assume this is still part of the Quality Systems requirement for a medical device company. So instead of auditing as a manufacturer, would they audit us on the quality aspect side of quality regulations? Any feedback is appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
------------------------------

Thank you Kevin for the quick, detailed response! Most appreciated! :)

Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
------------------------------

Original Message:
Sent: 22-Mar-2021 19:31
From: Kevin Randall
Subject: FDA Auditing Question

FDA has the statutory authority [Section 704(a) of the FD&C Act] to enter and inspect any factory, warehouse, or establishment in which devices are manufactured, processed, packed, or held, for introduction into interstate commerce.  FDA has a very liberal interpretation of "manufacture".  A general rule is that, if the operations in which the establishment is engaged exceed the registration thresholds of 21 CFR 807.20(a), and the establishment is not GMP-exempt, then such establishment is likely to be added to (or remain in) FDA's inspection queue.  A common version of this is where the firm is a specification developer who outsources device fabrication to a third party.  Whether that third party is a sister organization under the same corporate ownership, or whether it is an independent third party, the specification developer is, pursuant to 21 CFR 820.50, required to assure proper control of the fabricator.  FDA routinely inspects specification developers, and focuses heavily on design controls and purchasing controls (among other things like CAPA and complaint handling of course).

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 22-Mar-2021 18:54
From: Vicki Ong
Subject: FDA Auditing Question

Hello Regulatory Team Members,

I have a question regarding auditing facilities.  Since July of 2020, our company transitioned into a new company within the same organization, however, and we no longer manufacture products at our facility and all manufacturing products are done in our corporate facility in Japan.
In past, FDA has come into our facility for auditing.  Since we are no longer producing products, is FDA still required to come in for inspections? I assume they would because we are still classified as a Class 2 medical device company. I assume this is still part of the Quality Systems requirement for a medical device company. So instead of auditing as a manufacturer, would they audit us on the quality aspect side of quality regulations? Any feedback is appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
------------------------------

Hello Vicki,

This largely depends on how you have registered the establishments with the FDA on the FURLS site according to 21 CFR 807, i.e. Manufacturer, Contract Manufacturer, Complaint Handling Unit, etc.  The FDA will conduct an inspection at the site according to how the company has registered the facilities.  You will want to make sure each facility is properly registered.  Also the QMS should clearly identify the roles and responsibilities, including activities, which are performed at each site.  If a site is registered as the "Manufacturer" but the majority of the manufacturing and packaging activities occur at another location, the FDA will want to know this quite early in the inspection.  They get a little frustrated to find out later many activities are done at different facilities or even in countries.  If all manufacturing is done at your Japan facility, might want to consider registering the US as a Manufacturer and Japan as a Contract Manufacturer.  That way at least FDA knows majority of manufacturing would then or probably done in the Japan facility.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 22-Mar-2021 19:42
From: Vicki Ong
Subject: FDA Auditing Question

Thank you Kevin for the quick, detailed response! Most appreciated! :)

Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States

Original Message:
Sent: 22-Mar-2021 19:31
From: Kevin Randall
Subject: FDA Auditing Question

FDA has the statutory authority [Section 704(a) of the FD&C Act] to enter and inspect any factory, warehouse, or establishment in which devices are manufactured, processed, packed, or held, for introduction into interstate commerce.  FDA has a very liberal interpretation of "manufacture".  A general rule is that, if the operations in which the establishment is engaged exceed the registration thresholds of 21 CFR 807.20(a), and the establishment is not GMP-exempt, then such establishment is likely to be added to (or remain in) FDA's inspection queue.  A common version of this is where the firm is a specification developer who outsources device fabrication to a third party.  Whether that third party is a sister organization under the same corporate ownership, or whether it is an independent third party, the specification developer is, pursuant to 21 CFR 820.50, required to assure proper control of the fabricator.  FDA routinely inspects specification developers, and focuses heavily on design controls and purchasing controls (among other things like CAPA and complaint handling of course).

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 22-Mar-2021 18:54
From: Vicki Ong
Subject: FDA Auditing Question

Hello Regulatory Team Members,

I have a question regarding auditing facilities.  Since July of 2020, our company transitioned into a new company within the same organization, however, and we no longer manufacture products at our facility and all manufacturing products are done in our corporate facility in Japan.
In past, FDA has come into our facility for auditing.  Since we are no longer producing products, is FDA still required to come in for inspections? I assume they would because we are still classified as a Class 2 medical device company. I assume this is still part of the Quality Systems requirement for a medical device company. So instead of auditing as a manufacturer, would they audit us on the quality aspect side of quality regulations? Any feedback is appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
------------------------------

Thank you Richard for your informative reply to my question. I know for a fact our facility is not being registered as the Manufacturer. We are only registered as distributor, but we are representing Japan (our corp and manufacturer) for all U.S. FDA inquiries.

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
------------------------------

Original Message:
Sent: 23-Mar-2021 09:05
From: Richard Vincins
Subject: FDA Auditing Question

Hello Vicki,

This largely depends on how you have registered the establishments with the FDA on the FURLS site according to 21 CFR 807, i.e. Manufacturer, Contract Manufacturer, Complaint Handling Unit, etc.  The FDA will conduct an inspection at the site according to how the company has registered the facilities.  You will want to make sure each facility is properly registered.  Also the QMS should clearly identify the roles and responsibilities, including activities, which are performed at each site.  If a site is registered as the "Manufacturer" but the majority of the manufacturing and packaging activities occur at another location, the FDA will want to know this quite early in the inspection.  They get a little frustrated to find out later many activities are done at different facilities or even in countries.  If all manufacturing is done at your Japan facility, might want to consider registering the US as a Manufacturer and Japan as a Contract Manufacturer.  That way at least FDA knows majority of manufacturing would then or probably done in the Japan facility.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 22-Mar-2021 19:42
From: Vicki Ong
Subject: FDA Auditing Question

Thank you Kevin for the quick, detailed response! Most appreciated! :)

Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States

Original Message:
Sent: 22-Mar-2021 19:31
From: Kevin Randall
Subject: FDA Auditing Question

FDA has the statutory authority [Section 704(a) of the FD&C Act] to enter and inspect any factory, warehouse, or establishment in which devices are manufactured, processed, packed, or held, for introduction into interstate commerce.  FDA has a very liberal interpretation of "manufacture".  A general rule is that, if the operations in which the establishment is engaged exceed the registration thresholds of 21 CFR 807.20(a), and the establishment is not GMP-exempt, then such establishment is likely to be added to (or remain in) FDA's inspection queue.  A common version of this is where the firm is a specification developer who outsources device fabrication to a third party.  Whether that third party is a sister organization under the same corporate ownership, or whether it is an independent third party, the specification developer is, pursuant to 21 CFR 820.50, required to assure proper control of the fabricator.  FDA routinely inspects specification developers, and focuses heavily on design controls and purchasing controls (among other things like CAPA and complaint handling of course).

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 22-Mar-2021 18:54
From: Vicki Ong
Subject: FDA Auditing Question

Hello Regulatory Team Members,

I have a question regarding auditing facilities.  Since July of 2020, our company transitioned into a new company within the same organization, however, and we no longer manufacture products at our facility and all manufacturing products are done in our corporate facility in Japan.
In past, FDA has come into our facility for auditing.  Since we are no longer producing products, is FDA still required to come in for inspections? I assume they would because we are still classified as a Class 2 medical device company. I assume this is still part of the Quality Systems requirement for a medical device company. So instead of auditing as a manufacturer, would they audit us on the quality aspect side of quality regulations? Any feedback is appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
------------------------------

Hi Vicki,

Even you are no longer making the products in your facility, FDA can still come and audit the records of the products you made previously at this location if those products are still in the US market. 

Thanks,
Min 




------------------------------
Min Yao, Ph.D., RAC PhD, RAC
Strategic Advisor
Irvine CA
United States
------------------------------

Original Message:
Sent: 25-Mar-2021 12:10
From: Vicki Ong
Subject: FDA Auditing Question

Thank you Richard for your informative reply to my question. I know for a fact our facility is not being registered as the Manufacturer. We are only registered as distributor, but we are representing Japan (our corp and manufacturer) for all U.S. FDA inquiries.

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States

Original Message:
Sent: 23-Mar-2021 09:05
From: Richard Vincins
Subject: FDA Auditing Question

Hello Vicki,

This largely depends on how you have registered the establishments with the FDA on the FURLS site according to 21 CFR 807, i.e. Manufacturer, Contract Manufacturer, Complaint Handling Unit, etc.  The FDA will conduct an inspection at the site according to how the company has registered the facilities.  You will want to make sure each facility is properly registered.  Also the QMS should clearly identify the roles and responsibilities, including activities, which are performed at each site.  If a site is registered as the "Manufacturer" but the majority of the manufacturing and packaging activities occur at another location, the FDA will want to know this quite early in the inspection.  They get a little frustrated to find out later many activities are done at different facilities or even in countries.  If all manufacturing is done at your Japan facility, might want to consider registering the US as a Manufacturer and Japan as a Contract Manufacturer.  That way at least FDA knows majority of manufacturing would then or probably done in the Japan facility.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 22-Mar-2021 19:42
From: Vicki Ong
Subject: FDA Auditing Question

Thank you Kevin for the quick, detailed response! Most appreciated! :)

Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States

Original Message:
Sent: 22-Mar-2021 19:31
From: Kevin Randall
Subject: FDA Auditing Question

FDA has the statutory authority [Section 704(a) of the FD&C Act] to enter and inspect any factory, warehouse, or establishment in which devices are manufactured, processed, packed, or held, for introduction into interstate commerce.  FDA has a very liberal interpretation of "manufacture".  A general rule is that, if the operations in which the establishment is engaged exceed the registration thresholds of 21 CFR 807.20(a), and the establishment is not GMP-exempt, then such establishment is likely to be added to (or remain in) FDA's inspection queue.  A common version of this is where the firm is a specification developer who outsources device fabrication to a third party.  Whether that third party is a sister organization under the same corporate ownership, or whether it is an independent third party, the specification developer is, pursuant to 21 CFR 820.50, required to assure proper control of the fabricator.  FDA routinely inspects specification developers, and focuses heavily on design controls and purchasing controls (among other things like CAPA and complaint handling of course).

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 22-Mar-2021 18:54
From: Vicki Ong
Subject: FDA Auditing Question

Hello Regulatory Team Members,

I have a question regarding auditing facilities.  Since July of 2020, our company transitioned into a new company within the same organization, however, and we no longer manufacture products at our facility and all manufacturing products are done in our corporate facility in Japan.
In past, FDA has come into our facility for auditing.  Since we are no longer producing products, is FDA still required to come in for inspections? I assume they would because we are still classified as a Class 2 medical device company. I assume this is still part of the Quality Systems requirement for a medical device company. So instead of auditing as a manufacturer, would they audit us on the quality aspect side of quality regulations? Any feedback is appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Thank you for the valuable experience you give us by participating in this forum.
 
Sometimes we have a problem with this type of documentation where the manufacturer presents the FDA certificate, and we cannot observe the contracted manufacturing plant.
for us if not it is registered.

my question is:
Does the manufacturer in charge and responsible for the design and specifications of the device need an ISO 13485, to register in fda;
 even if this manufacturer contracts a plant in China to carry out the manufacturing?

thanks for your comments.

Original Message:
Sent: 25-Mar-2021 12:10
From: Vicki Ong
Subject: FDA Auditing Question

Thank you Richard for your informative reply to my question. I know for a fact our facility is not being registered as the Manufacturer. We are only registered as distributor, but we are representing Japan (our corp and manufacturer) for all U.S. FDA inquiries.

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States

Original Message:
Sent: 23-Mar-2021 09:05
From: Richard Vincins
Subject: FDA Auditing Question

Hello Vicki,

This largely depends on how you have registered the establishments with the FDA on the FURLS site according to 21 CFR 807, i.e. Manufacturer, Contract Manufacturer, Complaint Handling Unit, etc.  The FDA will conduct an inspection at the site according to how the company has registered the facilities.  You will want to make sure each facility is properly registered.  Also the QMS should clearly identify the roles and responsibilities, including activities, which are performed at each site.  If a site is registered as the "Manufacturer" but the majority of the manufacturing and packaging activities occur at another location, the FDA will want to know this quite early in the inspection.  They get a little frustrated to find out later many activities are done at different facilities or even in countries.  If all manufacturing is done at your Japan facility, might want to consider registering the US as a Manufacturer and Japan as a Contract Manufacturer.  That way at least FDA knows majority of manufacturing would then or probably done in the Japan facility.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 22-Mar-2021 19:42
From: Vicki Ong
Subject: FDA Auditing Question

Thank you Kevin for the quick, detailed response! Most appreciated! :)

Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States

Original Message:
Sent: 22-Mar-2021 19:31
From: Kevin Randall
Subject: FDA Auditing Question

FDA has the statutory authority [Section 704(a) of the FD&C Act] to enter and inspect any factory, warehouse, or establishment in which devices are manufactured, processed, packed, or held, for introduction into interstate commerce.  FDA has a very liberal interpretation of "manufacture".  A general rule is that, if the operations in which the establishment is engaged exceed the registration thresholds of 21 CFR 807.20(a), and the establishment is not GMP-exempt, then such establishment is likely to be added to (or remain in) FDA's inspection queue.  A common version of this is where the firm is a specification developer who outsources device fabrication to a third party.  Whether that third party is a sister organization under the same corporate ownership, or whether it is an independent third party, the specification developer is, pursuant to 21 CFR 820.50, required to assure proper control of the fabricator.  FDA routinely inspects specification developers, and focuses heavily on design controls and purchasing controls (among other things like CAPA and complaint handling of course).

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 22-Mar-2021 18:54
From: Vicki Ong
Subject: FDA Auditing Question

Hello Regulatory Team Members,

I have a question regarding auditing facilities.  Since July of 2020, our company transitioned into a new company within the same organization, however, and we no longer manufacture products at our facility and all manufacturing products are done in our corporate facility in Japan.
In past, FDA has come into our facility for auditing.  Since we are no longer producing products, is FDA still required to come in for inspections? I assume they would because we are still classified as a Class 2 medical device company. I assume this is still part of the Quality Systems requirement for a medical device company. So instead of auditing as a manufacturer, would they audit us on the quality aspect side of quality regulations? Any feedback is appreciated.

Thanks,
Vicki

------------------------------
Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
------------------------------