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Recalls and the FDA

At a recent seminar on Drug and Device Recalls in Indianapolis, the following are some insights in how the FDA perceives company’s recall problems and what they expect from a recalling company for the source itself – the FDA.

Companies try to minimize their problem when discussing their problems with the FDA recall coordinator. This leads the FDA down the road of “that is the real story?”

The FDA is still planning to post recalls in real time but that program had not been implemented yet. The FDA has a fire wall on the real time recall logging process and at the present time there are approximately 2800 recalls posted, over the last 12 months.

Companies should use their website for recall notification. The site should have a recall link.

For products that are distributed outside the USA only, you must time notify the FDA of any recall – Global Harmonization.

• Follow the FDA guidelines with status reports to the FDA.
• There would be no FDA effectiveness checks.
• The notification of a recall of a foreign distributed only, it could trigger an inspection.

Class III may still be reportable and 803A6 actionable.

When you have a recall you maybe telling the FDA (or they may think that):

•  QA is working or not
•  Management is willing to address the problem
•  Your thought process
•  State of control of the firm

When should you call the FDA of a problem or even a potential problem?

• Start of the investigation (the FDA feels that this is the time to call them, even to explain that you have started an investigation and will follow up with them when you learn more.)
• After action is taken (the FDA may not agree with you on the action causing additional problems or actions.)

All recalls are voluntary? NOT!!!

• Pressured by the FDA – Seizure, prosecution, injunctions

Drug/Device combo – a recall will be handled by the Drug division not Device.

The FDA wants to see you conduct a risk health hazard assessment on a problem

• To a population
• Possible frequency
• use multi-tiers of the evaluation
• Worse case scenario
  • What could happen in the worse case scenario?
• The FDA wants to see your thought process used in the health hazard evaluation.

When to close a recall?

• The effort is most important.
  • Reasonable efforts
• Life of the device.
• Population involved in the recall.

Recalls are only negative input on a company – they cannot be considered positive.

• Priority for an inspection.

The FDA will want to review your investigation matrix (similar to a CAPA investigation).

Any comments and questions please email us at info@mdiconsultants.com

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