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February 8th 2007: Custom Ultrasonics Signs Consent Decree with FDA

The Food and Drug Administration (FDA) announced yesterday that Custom Ultrasonics, Inc., has signed a consent decree of permanent injunction in which it has agreed to stop manufacturing and distributing its System 83 Plus Washer/Disinfector and the System Plus 83 Mini-flex Washer/Disinfector until it brings the methods and controls used to manufacture the devices into compliance with FDA's Current Good Manufacturing Practice requirements of its Quality System (QS) regulation. In addition, the company has agreed to develop and implement adequate written medical device reporting procedures.

The company's non-compliance with Quality System Regulations (QSR) posed a potential public health hazard because endoscopes that are not properly cleaned and disinfected can be a source of transmission of pathogens between patients, causing life threatening infections. Till date, FDA is not aware of any adverse events fortunately.

Consent Decrees are usually enforced when a company repeatedly violates cGMP (Good Manufacturing Practices)/QSR requirements. Under these circumstances, FDA makes a legal agreement with the firm, enforceable in a federal court that forces the company to make specific changes. In addition to change requirements and deadlines for their completion, the company may be required to pay fines, reimbursements to government for inspection costs and other penalties for non-compliance.

Such outcomes are easily avoidable if the company takes timely action in response to FDA concerns. Even if a company doesn’t have the requisite competence in-house to deal with such issues, the same can be easily addressed by taking advice from outside regulatory consultants.

For the complete FDA Update, please visit:

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01556.html

If you have comments regarding this update, please contact Romil Rambhia at 516-482-9001 or email at romil@mdiconsultants.com

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