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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Davis Schottlander and Davis, Ltd 01-Apr-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Center for Devices and
Radiological Health
2098 Gaither Road
Rockville, MD 20850


WARNING LETTER

APR 1 2004

VIA FEDERAL EXPRESS

Brian Schottlander, Managing Director
Davis Schottlander and Davis Ltd.
Fifth Avenue
Letchworth Garden City, Herts
SG6 2WD
United Kingdom

Dear Mr. Schottlander:

During an inspection of your establishment located in Letchworth Garden City, Herts, UK on December 15-18, 2003, our investigator determined that your firm manufactures plastic/acrylic denture teeth and denture resin material. These products are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 351(H).

The above-stated inspection revealed that these devices are adulterated under section 501(h) of the Act, in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following:

Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a)(3). Specifically, the firm's complaint handling procedures do not mention or have instructions for evaluating complaints for reporting to FDA according to the Medical Device Reporting regulations.

Additionally, the above-stated inspection revealed that your devices are misbranded under Section 502(t)(2) of the Act, in that your firm failed or refused to furnish any material or information as required by Section 519 respecting the device and the Medical Device Reporting (MDR) regulation, Title 21 CFR, Part 803. Your firm failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. Specifically, your firm failed to have specific procedures for reporting adverse events to FDA, including the evaluation of adverse events received, the directions for reporting events within required time frames, and the method by which the events are reported.

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. In addition, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Include all documentation of the corrective action you have taken. If the documentation is not in English, please provide a translation to facilitate our review.

Your response should be sent to Keisha Thomas, Consumer Safety Officer, Center for Devices and Radiological Health, Food and Drug Administration, 2094 Gaither Road, Rockville, MD 20850. If you have any questions regarding this letter, please contact Ms. Thomas at (301) 594-4613.

Sincerely yours,

/S/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health