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U.S. Department of Health and Human Services

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OCD FY2000: Regulatory compliance

  • Our Center and FDA’s Winchester Engineering and Analytical Center (WEAC), together with the Consumer Electronics Association (CEA), are planning to sponsor a course to train manfacturers’ personnel on the Federal requirements for television products under Chapter V of the Federal Food, Drug and Cosmetic Act. FDA and CEA have developed video tapes for the course which emphasize compliance with the performance standard for television receivers in section 1020.10 of Title 21 of the Code of Federal Regulations (21 CFR 1020.10) and procedures for testing products for compliance.
  • The promotion and advertising of devices over the internet has expanded dramatically within the last year. In an effort to assure that the information provided on the internet is truthful and otherwise in conformance with the Food Drug and Cosmetic Act (FD&C Act), we have devoted significant resources to monitoring the internet. In 2000, we issued 22 warning letters to firms advertising on the internet. No additional follow-up regulatory action has been necessary, thus far.

Stimulator

A United States District Court judge ordered Universal Management Services, Inc. of Akron, Ohio, the maker and distributor of a gas grill igniter marketed for pain relief, to begin refunding approximately $82.00 to each purchaser of the fraudulent medical device. Letters have been mailed to over 500,000 consumers who bought the device called the Stimulator. This is the first case brought under the Federal Food, Drug, and Cosmetic Act in which a company has been ordered to pay restitution to consumers.

Abbott Laboratories

Abbott Laboratories, a major manufacturer of in vitro diagnostic devices, entered into a consent decree of permanent injunction with the Department of Justice on November 4, 1999, paying $100 million and ceasing shipment of several of its devices manufactured at the firm's northern Illinois plants. Several other devices manufactured by the firm continue to be available due to the medical necessity of these products. FDA requested the permanent injunction after Abbott failed to comply with Good Manufacturing Practice (GMP) and Quality System requirements and to fulfill past commitments to correct existing deficiencies. The $100 million payment sets a precedent as the largest amount of money ever paid by an FDA-regulated company for a violation of the Federal Food, Drug, and Cosmetic Act.

Lifescan

Lifescan admitted in a plea agreement that it failed to describe defects in their device to the Food and Drug Administration when it was trying to gain clearance to sell their SureStep Blood Glucose Monitoring System. Lifescan pleaded guilty to criminal charges and agreed to pay $60 million in fines for selling defective blood glucose monitoring devices to diabetics and submitting false information about the problems to FDA. The Settlement Agreement, dated December 15, 2000, requires the company to submit to CDRH a monthly report of complaints and analyses for seven specific categories of complaints about SureStep or SureStep Pro Blood Glucose Monitoring Systems.

Metrex Research Corp.

As part of an Office of Compliance project to evaluate chemical sterilants and high level disinfectants, an inspection and sample request for Metrex Research Corporation’s ProCide NS Reusable Activated Dialdehyde Sterilizing and Disinfecting Solution resulted in a Warning Letter for deviations from the Quality System Regulation. FDA’s lab testing revealed failure to achieve sterilization or high level disinfection, resulting in a Class I recall. Testing by the firm’s independent laboratory revealed product failure of the tuberculocidal test. Metrex has stopped manufacturing and distributing ProCide products pending validation of their manufacturing processes, and improvement of their product efficacy and stability.

Laser Vision Centers, Inc. (LVCI)

LVCI agreed to pay a total of $1.5 million in Civil Money Penalties for their involvement in the illegal distribution of “Bermuda Cards” that enabled VISX excimer lasers to be used for capabilities beyond those approved by FDA. After an extensive discovery process, LVCI decided not to go to court, and agreed to pay the fine.

(Revised 1/30/2001)