INSIGHT REPORT
Vol 4  #7
August
2001

INSIGHT REPORT

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Insight Report No. 4 Vol. 7

What the FDA wants to Know about your Recalled Product.

Recalls, or as the FDA now calls it, Corrections and Removal, are a very serious business. The removal or correction of a product means that your product did not meet specifications. Or in the FDA language, "your device was distributed in an adulterated or misbranded condition."

We all know that accidents or problems happen and it would almost be impossible to assure that you would never have a recall. But, to the FDA there is nothing as an accident or "problems occur."

It is a company's responsible to assure that only safe and effective products are distributed and that they meet specification for their intended life span. It is the FDA's responsibility to make sure that companies have a fully implemented Quality System and that they are in control of their operations.

Besides the fact that the FDA wants to make sure that the adulterated or misbranded product is remove or corrected in an expedite manner, they would be more interested to learn if the company had determined what caused the problem in the first place. They want to know how the company addressed the problem and was the root cause determined and what corrective action was taken to assure that the problem will not reoccur.

What will the FDA look for during an inspection as a result of a product removal or corrective?

There are several areas that will be of the greatest interest to the FDA during such a follow up. These areas include:

• Design Review
• Change Control
• 510(k)
• Process Validations
• CAPA
• Decision Time Line

Design Review:
For Post 1997 cleared devices, the FDA will expect that the products were developed using the Design Review requirements of the QSR. The FDA will want to review the Design History File (DHF). One of the main areas of concern is if a design "Validation" was performed. Design validation requires that you test production units of the device under actual or simulated use conditions to ensure that the device conforms to defined user need and intended uses.

Change Control:
If a device was Pre 1997 cleared, the FDA will require that any changes to the design be conducted using the Design Review requirements of the QSR.
Was the change determined to require design review and if now why not. Was there a Design Plan, did the Output meet the Input requirements, and again there was a design validation conducted to determine that the user needs and that the intended use could be met in simulated and/or actual condition testing?

510(k):
Did the device have a 510(k) and if so were there any changes to the labeling or specifications of the device? If so, was it determined if another 510(k) or 510(k) update to the FDA required?

Process Validations:
If you have been monitoring the FDA injunctions in the past few years, the main reason for these injunctions, whether they are involving medical device, in-vitro diagnostic or pharmaceutical companies, has been either a lack of or improper process validations. The FDA will want to determine if the processes used in the manufacturing of your devices, especially those involved in the recall were validated. You have to assure that any process that cannot be inspected is properly validated to provide you the assurance that it would meet specifications. The FDA would want to review the process validation file for each operation.

CAPA:
Was there a CAPA procedure in place and if so was it being implemented? What was the root cause of the problem and what was the corrective action to prevent the problem from reoccurring? Could have this route cause affected other devices or processes?

Decision Time Line:
This is an area that could be very critical, especially if there were deaths or serious injuries involved in your decision to recall your device. In determining your time line for recalling your product the FDA could determine possible negligence and take more appropriate legal actions against the firm or even the firm's officers. This time line could also cause you serious liability damages. So to determine the Decision Time Line the FDA would be interested in learning when did the company learn of the problem? How long did the company take to make a corrective action? When did the company notify the FDA? Was the MDR requirements met?

Recalls or Removals and Corrections are the result of unexpected or unanticipated situations. No one wants to conduct them and especially no one wants to have to call the FDA and explain that you are going to remove or correct a product. But, they happen and if you are in business long enough you will probably be involved in a recall at some time. This is where a well-implemented quality system will provide you the procedures and documentation to be able to handle the recall effective and more important deal with the regulatory agency.

Next Insight Report - What is a Preventative Action? or Is a Preventative Action the same as a Corrective Action?

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
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