Heraeus Kulzer GmbH 6/16/11
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
June 16, 2011
VIA UNITED PARCEL SERVICE
Dr. Martin Haase
Heraeus Kulzer GmbH
Gruener Weg 11
63450 Hanau, Germany
Dear Dr. Haase:
During an inspection of your firm located in Dormagen, Germany, on March 7, 2011, through March 10, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures dental impression materials. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Our inspection revealed that your dental impression materials devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 - Medical Device Reporting regulation. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, your firm has no procedure for reporting MDR reportable events regarding your dental impression materials for incidents that occurred outside of the U.S. Your firm’s procedure (SOP 8.2.1 # HKG Medical Devices Vigilance) provided during the inspection only applies to reporting incidents within the European Union.
We received a response from i.V. Stefan Semmel, Site Manager Dormagen, dated April 6, 2011. We reviewed the response and conclude that it is not adequate because your firm’s revised MDR procedures fail to include how your firm is required to develop, maintain, and implement written MDR procedures establishing internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. The revised procedure also fails to include a standardized review process or procedure for determining when an event meets the criteria for reporting, timely transmission of complete medical device reports, and documentation and record keeping requirements, as required by 21 CFR 803.17.
U.S. 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 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent this violation, or similar violation, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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. Please provide a translation of documentation not in English to facilitate our review.
Your response should be sent to: Mr. Allen Wynn, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO-66 Room 2614, Silver Spring, Maryland 20993-0002. Refer to CMS case #184372 when replying. If you have any questions about the content of this letter please contact:
Mr. Ronald Swann at (301) 796-5770.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violation, and take prompt actions to correct the violation and to bring your products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and