Is a registrar obligated to inform the FDA of NCRs that could be considered 483s?

[Pataha]

If your ISO Registrar were also certified as a third party FDA Auditor, would they be obligated to inform the FDA of NCRs that could be considered 483s?

 

[Al Rosen]

If your ISO Registrar were also certified as a third party FDA Auditor, would they be obligated to inform the FDA of NCRs that could be considered 483s?

If they were, they would lose a lot of business. So, I doubt it.

 

[Sidney Vianna]

Risk risk risk

From (broken link removed)

K. What Inspection Records Are to be Submitted to FDA?
APs will need to prepare an FDA prescribed report, using the format defined in the Investigations Operations Manual (IOM), (broken link removed) subchapters 559 and 590. Also see List of Observations, (broken link removed). FDA will provide instruction in the preparation of a list of observations and the report at the FDA training course. See Regulatory Procedures Manual: (broken link removed) for timeframes for submitting reports.

At the conclusion of the inspection, when deficiencies have been observed, the AP Inspector lists all significant objectionable conditions observed and presents them in writing to notify the manufacturer’s top management of significant objectionable conditions. Each observation is discussed with the firm’s most responsible person at the facility. In addition, the AP inspector will prepare and send a report to FDA and the manufacturer’s designated representative at the same time, but no later than three weeks following the last day of the inspection. As required by section 704(g)(7)(B), the report, at a minimum shall:

• identify the persons responsible for compliance with the QS regulation;
• include the date(s) of the inspection;
• include the scope of the inspection;
• describe in detail each observation identified and presented in writing to the establishment’s management at the conclusion of the inspection;
• identify other matters that relate or that may influence compliance with the act;
• describe any recommendations made to the establishment during the inspection or at the inspection’s closing meeting; and descri
• be any promised corrective actions or other discussions with management at the conclusion of the inspection.

FDA expects the APs' reports and any clarifying information requested by FDA to be provided in English. Any documents collected from the manufacturer may be in the operational or working language used in the manufacturer’s facility. However, the time necessary to translate the firm’s documents may delay FDA’s endorsement.

FDA may not be able to evaluate and classify an inspection report submitted by an AP if the information discussed above is not included. If information necessary for the agency's review is not included, we will begin our review only after we receive the necessary information.

If at any time during an inspection the AP discovers a condition that it believes could cause or contribute to an unreasonable risk to public health, the AP must report the problem to FDA immediately.

 

[Al Rosen]

From (broken link removed)

K. What Inspection Records Are to be Submitted to FDA?
APs will need to prepare an FDA prescribed report, using the format defined in the Investigations Operations Manual (IOM), (broken link removed) subchapters 559 and 590. Also see List of Observations, (broken link removed). FDA will provide instruction in the preparation of a list of observations and the report at the FDA training course. See Regulatory Procedures Manual: (broken link removed) for timeframes for submitting reports.

At the conclusion of the inspection, when deficiencies have been observed, the AP Inspector lists all significant objectionable conditions observed and presents them in writing to notify the manufacturer’s top management of significant objectionable conditions. Each observation is discussed with the firm’s most responsible person at the facility. In addition, the AP inspector will prepare and send a report to FDA and the manufacturer’s designated representative at the same time, but no later than three weeks following the last day of the inspection. As required by section 704(g)(7)(B), the report, at a minimum shall:

• identify the persons responsible for compliance with the QS regulation;
• include the date(s) of the inspection;
• include the scope of the inspection;
• describe in detail each observation identified and presented in writing to the establishment’s management at the conclusion of the inspection;
• identify other matters that relate or that may influence compliance with the act;
• describe any recommendations made to the establishment during the inspection or at the inspection’s closing meeting; and descri
• be any promised corrective actions or other discussions with management at the conclusion of the inspection.

FDA expects the APs' reports and any clarifying information requested by FDA to be provided in English. Any documents collected from the manufacturer may be in the operational or working language used in the manufacturer’s facility. However, the time necessary to translate the firm’s documents may delay FDA’s endorsement.

FDA may not be able to evaluate and classify an inspection report submitted by an AP if the information discussed above is not included. If information necessary for the agency's review is not included, we will begin our review only after we receive the necessary information.

If at any time during an inspection the AP discovers a condition that it believes could cause or contribute to an unreasonable risk to public health, the AP must report the problem to FDA immediately.

Sidney, my assumption was that the ISO Registrar was not performing an FDA inspection, just a third party audit. There is a difference. If my registrar is auditing my organization, then I am paying him to audit to ISO 9001 not the FDA QSR.

 

[Sidney Vianna]

Sidney, my assumption was that the ISO Registrar was not performing an FDA inspection, just a third party audit. There is a difference. If my registrar is auditing my organization, then I am paying him to audit to ISO 9001 not the FDA QSR.

OK, Al, when I first read the original question, I had understood that the scenario was for a Registrar also working as an "Accredited Person" under the FDA program.

 

[Al Rosen]

OK, Al, when I first read the original question, I had understood that the scenario was for a Registrar also working as an "Accredited Person" under the FDA program.

BTW, I was reassesed and upgraded to 13485:2003 last week by two APs.

 

[Pataha]

Sorry, I may not have worded the question well. Al's Interpretation is the scenrio, I was attempting to present. However, Sidney has an interesting point of it being:

"If at any time during an inspection the AP discovers a condition that it believes could cause or contribute to an unreasonable risk to public health, the AP must report the problem to FDA immediately. "

Wouldn't they then be required to report to the FDA?
The ISO Auditor that we use, that includes CMDCAS, would report to Health Canada if the above situation was occurring. Since, they are also going to provide a component for the FDA QSR, would that not include them?

 

[Pataha]

Al,
Congrats, on the ISO 13485:2003 upgrade

 

[Jim Wynne]

I'm not an expert in this area but...
The phrase "during the inspection" refers, I think to an FDA inspection. Thus if an auditor were doing an ISO audit and happened to observe an FDA violation, I don't think she would be in violation of the FDA requirements by not reporting it.
This is apart from any ethical considerations, of course.