Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

If a company has obtained clinical supplies from a CMO and the CMO receives a warning letter from the FDA, can the company continue to be supplied by the CMO with clinical supplies for an ongoing trial?

Anon,

The regulatory answer is yes, but the actual answer might be more involved.  Receipt of a Warning Letter from the US FDA indicates the company has significant compliance issues (there are lots of legal and regulatory phrases here which can be used).  Even though a company has a Warning Letter, this does not prevent them from manufacturing or supplying products.  A company would have to go under further regulatory restrictions such as Injunctions where the products could not be sold or distributed.  Now, the involved answer is understanding, as you are the customer, what is the nature of Warning Letter content and how it may impact the ongoing clinical trial.  Sometimes Warning Letters have to do with quality system processes like corrective action, sometimes they deal with manufacturing processes like validations, and sometimes they deal directly with the product like monitoring and measuring during manufacturing.  It would probably be a good recommendation to determine how this Warning Letter impacts the clinical trial from the supplies being obtained and if there would be issues from the clinical trial study.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Oct-2022 09:04
From: Anonymous Member
Subject: Clinical samples after a warning letter

This message was posted by a user wishing to remain anonymous

If a company has obtained clinical supplies from a CMO and the CMO receives a warning letter from the FDA, can the company continue to be supplied by the CMO with clinical supplies for an ongoing trial?

Agreed with Richard's wise counsel.  I would add that such additional vetting of the CMO must be executed as part of your organization's supplier/purchasing control and risk management mechanisms.  You need to carefully use those mechanisms to decide (and document) commensurate with risk whether the CMO's Warning Letter would alter the status of the CMO's eligibility / acceptability to continue providing the products / services to your organization.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 12-Oct-2022 04:21
From: Richard Vincins
Subject: Clinical samples after a warning letter

Anon,

The regulatory answer is yes, but the actual answer might be more involved.  Receipt of a Warning Letter from the US FDA indicates the company has significant compliance issues (there are lots of legal and regulatory phrases here which can be used).  Even though a company has a Warning Letter, this does not prevent them from manufacturing or supplying products.  A company would have to go under further regulatory restrictions such as Injunctions where the products could not be sold or distributed.  Now, the involved answer is understanding, as you are the customer, what is the nature of Warning Letter content and how it may impact the ongoing clinical trial.  Sometimes Warning Letters have to do with quality system processes like corrective action, sometimes they deal with manufacturing processes like validations, and sometimes they deal directly with the product like monitoring and measuring during manufacturing.  It would probably be a good recommendation to determine how this Warning Letter impacts the clinical trial from the supplies being obtained and if there would be issues from the clinical trial study.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 11-Oct-2022 09:04
From: Anonymous Member
Subject: Clinical samples after a warning letter

This message was posted by a user wishing to remain anonymous

If a company has obtained clinical supplies from a CMO and the CMO receives a warning letter from the FDA, can the company continue to be supplied by the CMO with clinical supplies for an ongoing trial?

All very wise counsel.  I only add that whether a drug or device, the Quality Assurance of supplier selection and qualification and even audit of the CMO must be re-evaluated in addition to purchasing control sand risk management, to quickly assess the suitability of the manufacturer to continue to conduct services contracted.  In other words the sponsor must conduct due diligence with the knowledge that the CMO received a warning letter and document that there is no concern with the CMO supplying product for clinical use in the past and in the future based on the warning letter details. All of this must focus on product quality and patient safety.




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Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
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Original Message:
Sent: 17-Oct-2022 17:16
From: Kevin Randall
Subject: Clinical samples after a warning letter

Agreed with Richard's wise counsel.  I would add that such additional vetting of the CMO must be executed as part of your organization's supplier/purchasing control and risk management mechanisms.  You need to carefully use those mechanisms to decide (and document) commensurate with risk whether the CMO's Warning Letter would alter the status of the CMO's eligibility / acceptability to continue providing the products / services to your organization.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 12-Oct-2022 04:21
From: Richard Vincins
Subject: Clinical samples after a warning letter

Anon,

The regulatory answer is yes, but the actual answer might be more involved.  Receipt of a Warning Letter from the US FDA indicates the company has significant compliance issues (there are lots of legal and regulatory phrases here which can be used).  Even though a company has a Warning Letter, this does not prevent them from manufacturing or supplying products.  A company would have to go under further regulatory restrictions such as Injunctions where the products could not be sold or distributed.  Now, the involved answer is understanding, as you are the customer, what is the nature of Warning Letter content and how it may impact the ongoing clinical trial.  Sometimes Warning Letters have to do with quality system processes like corrective action, sometimes they deal with manufacturing processes like validations, and sometimes they deal directly with the product like monitoring and measuring during manufacturing.  It would probably be a good recommendation to determine how this Warning Letter impacts the clinical trial from the supplies being obtained and if there would be issues from the clinical trial study.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 11-Oct-2022 09:04
From: Anonymous Member
Subject: Clinical samples after a warning letter

This message was posted by a user wishing to remain anonymous

If a company has obtained clinical supplies from a CMO and the CMO receives a warning letter from the FDA, can the company continue to be supplied by the CMO with clinical supplies for an ongoing trial?