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U.S. Department of Health and Human Services

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OCD FY2003: Regulatory Compliance: Significant Compliance Actions

Dr. Leon LaHaye/LaHaye Center’s Laser System for LASIK

CDRH approved a $1.1 million Civil Money Penalty action against Dr. LaHaye and his center for using an unapproved laser on patients before he initiated a study. In addition, Dr. LaHaye treated more subjects than allowed under the study plan that was ultimately approved by the Center. He ignored the parameters established in the study by treating nearsightedness beyond the permitted range and by treating astigmatism and both eyes of some patients. The violations involved studies of a laser system built by LaHaye for LASIK treatment of nearsightedness.

Counterfeit Ethicon Corporation’s Prolene Surgical Mesh

In October 2003, Ethicon discovered two counterfeit lots of their Prolene Surgical Mesh in domestic commerce. This device is a flat nonabsorbable mesh used for hernia repair and other fascial deficiencies. The lots of mesh appeared to have been imported from a foreign country, and the Center issued an Import Alert to prevent additional product from entering the country. Preliminary testing by an FDA laboratory indicated that both lots of counterfeit Prolene surgical mesh were bacterially contaminated. After consultation with the Center, Ethicon recalled all product from their distributors and end users. The Center issued a Web Notification to inform the public of this problem. Additional microbiology and physical testing are in progress.

Decorative Contact Lenses

On April 1, 2003, the Center approved the issuance of an Import Alert (IA #86-10) for Decorative Contact Lenses. This Import Alert, which is entitled, “Detention without Physical Examination of Decorative Contact Lenses”, defines decorative contact lenses as cosmetics which are intended to alter the appearance of the eye for decorative fashion. Without consultation with a qualified eye care professional practitioner, these products have a high risk of damaging ocular health by causing corneal infection, as well as cornel scarring and potential blindness. Although, CDRH has taken the lead for decorative contact lenses enforcement, CDRH relies on CFSAN for all consults on decorative contact lenses. CFSAN’s consults address the violations (Sections 601(a), 601(e) & 602(a) of the Federal Food, Drug and Cosmetic Act) used for decorative contact lenses.

Adven Medical

Adven Medical, Inc., Lubbock, Texas, entered into a Consent Decree of Permanent Injunction in August 2003, for significant, numerous, and repeated violations to the Quality System regulation. Adven Medical, Inc., was a third-party reprocessor of various single use only devices. The firm’s most significant violation was the failure to validate the sterilization and cleaning process. They were also cited for violations regarding design controls, corrective and preventive actions, quality control, cleaning processes, device specifications, training, production and process controls, acceptance activities, control of measurement equipment, purchasing controls, device master records, and documentation controls. Adven Medical, Inc., claimed they corrected all of the above violations, however a subsequent district inspection revealed that none of the corrections made by the firm were adequate. As a result, Adven Medical Inc., believed it could not meet the requirements of the Quality System regulation, and permanently closed its business on October 15, 2003.

Multidata Systems Intl., Radiation Therapy

FDA entered into a consent decree of injunction with Multidata Systems International Corporation to stop them from manufacturing radiation therapy medical devices. Multidata Systems International manufactures devices for use in the treatment of cancer. The company’s radiation treatment planning software reportedly contributed to 28 patients receiving excessive amounts of radiation in a Panama facility. Several patients subsequently died. Multidata failed to conform to the Quality System regulation, and also failed to file prompt reports with the FDA after it became aware that its products may have caused or contributed to death or serious injury. A review of the firm’s regulatory history revealed that the firm had a history of failing to comply with the Quality System regulation. The consent decree enjoins Multidata from marketing its radiation therapy medical devices until FDA is satisfied that the firm has corrected its problems.

ADI Corporation

ADI Corporation manufactures computer monitors and televisions. The firm agreed to pay $475,000 for violating the Electronic Product Radiation Control Provisions of the Federal Food, Drug, and Cosmetic Act for continuing to certify and ship products to the United States after FDA disapproved its quality control and testing program. This problem was identified when FDA investigators conducted an inspection of ADI Systems Mexico, S.A. de C.V. and the investigators reported a number of serious deficiencies, including the failure of factory technicians to test computer monitors for compliance with the Federal radiation exposure limit under required testing conditions. FDA issued a Warning Letter, disapproving ADI Systems Mexico’s quality control and testing program for computer monitors and television receivers, making it illegal for them to certify these television products. FDA placed ADI Mexico on import detention and detained products automatically at the port of entry until the disapproval of the quality control and testing program had been rescinded. Thereafter, ADI Corporation shipped at least 55,000 computer monitors and television receivers into the United States, despite the agency’s warning that such shipments would violate the Act, and this led to the $475,000 fine.

 Registration and Listing

The Registration and Listing (R&L) staff initiated a pilot project to replace the distribution of paper copies of monthly establishment registration and device listing information change reports to FDA District Office Device Registration Monitors with an electronic copy sent via e-mail. This pilot project was a success and this paperless process is now permanent. This initiative saves supplies and resources. It also ensures that this critical change information is issued to FDA District Offices in a timely manner.

 Application Integrity Policy

The Division of Bioresearch Monitoring placed AGA Medical Corporation on the Application Integrity Policy (AIP). This action stops the substantive review of all new or pending applications before the agency. The AIP was put into place due to concerns that there was a system-wide failure by AGA to ensure the integrity of data submitted to FDA in support of research and marketing permits. The firm will be required to submit a detailed corrective and preventative action plan, and submit to a follow-up inspection once corrections have been made.

 Bioresearch Monitoring (BIMO) Activities

As a result of BIMO inspections, the CDRH’s Office of Device Evaluation (ODE) integrity officer placed integrity holds on 5 premarket submissions in FY 03 due to incomplete or fraudulent data. These initial actions will, in some cases, lead to additional enforcement actions including invocation of the AIP, rescission of applications, or disqualification of clinical investigators.

 Compliance Activities

Inspection Prioritization

CDRH researched existing inspection prioritization models and developed a flexible modular approach for prioritizing device inspections. In addition, CDRH established a draft “criteria list” for prioritizing inspections and developed a risk-based work planning model which incorporates an annual and quarterly review of adverse event and other risk-based databases and inspection results. As part of the work planning model, CDRH is responsible of providing a listing of foreign manufacturers to be inspected under the risk management strategy to ORA. ORA will conduct inspections of both domestic and foreign medical device manufacturers in accordance with the criteria established under the Center’s risk management strategy.

Third-Party Inspectors Under MDUFMA

CDRH has the responsibility of accrediting and training third-party inspectors under MDUFMA. In FY 03 it received 23 applications for third-party accreditation. Seventeen applications are under full review, five are under initial review and one application was denied.

Inspections and Product Testing

CRDH provided input to the FY 03 and FY 04 radiological health work plan for the FDA Office of Regulatory Affairs. CDRH revised definitions and provided updates for radiological health inventory for cabinet x-ray, laser, and sunlamp products in related compliance programs.