• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Section Contents Menu

Enforcement Actions

Nardi, Claudia 21-Nov-06

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

Public Health Service
Food and Drug Administration

 

9200 Corporate Boulevard
Rockville, Maryland 20850



NOV 2 1 2006

WARNING LETTER

VIA FEDERAL EXPRESS {AND FACSIMILE}

Claudia Nardi
Vice President
Rhein' 83 S .r.l.
Via Emilio Zago
8 Bologna, 40128, Italy

Dear Ms. Nardi:

During an inspection of your firm located in Bologna, Italy on June 19, 2006, through June 22, 2006, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures endosseous implant abutments and dental attachments. 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. We received a response from Claudia Nardi, Quality Manager, dated October 23, 2006, concerning our investigator's observations. We have reviewed your response and have concluded that it is inadequate because the attachments and other supporting documents are not in English and can not be thoroughly reviewed.

Our inspection revealed that several of the endosseous implant abutments and dental attachments are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). These devices are also misbranded under section 502(o) the Act 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce these devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is available through the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

More specifically, your firm has made changes to several of your devices since the clearance of the 510(k) for these devices. These changes require the submission of a new premarket notification submission as required section 510(k) of the Act, 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3)(i), in that the change or modification in the device could significantly affect the safety or effectiveness of the device. The changes that require you to submit a new 510(k) include the following:

  • The product modifications addressed in your February 16, 1999, letter to the agency regarding titanium screws;

  • The [redacted] an implant technique which attaches caps to the abutments. Although precision attachments (those that connect a denture to another denture or to a crown or bridge) are exempt from premarket notification requirements under 21 CFR 872.3165, your attachments do not fall within the exemption because they attach directly to an abutment;

  • The change from [redacted] to [redacted] Block Amides;

  • The modification of your [redacted] sphere to a [redacted] repair sphere, as described in your February 6, 2001, letter to the agency.

Lastly, your firm has made a change in the material for the "protective disk" to [redacted]. Please explain if this protective disk is a component of the Pivot cap and its indications. It also appears that the indications for your caps and this protective disk are beyond that of precision attachments. If this disk comes into contact with the patient, the abutment, or the implant, then a 510(k) is needed. Please provide clarification on these issues.

This inspection revealed that your devices are misbranded under section 502(f)(1) of the Act, 21 U.S.C. 352(f)(1), in that the labeling for the devices fail to bear adequate directions for use for the purposes for which they are intended. Your endosseous implant abutments do not have a prescription legend on the packaging, which is required by FDA. Additionally, your firm uses the symbol of the triangle with the exclamation point inside on your labeling. This symbol must either be removed or an English text translation must be next to it, as this symbol is not recognized in the United States. Also, the maintenance instructions for your devices are inadequate in that there is no information regarding what maintenance is required or recommendations for the frequency.

Given the serious nature of the violations of the Act, the dental attachments and abutments manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your response is adequate, and we may need to re-inspect your facility to verify} that the appropriate corrections have been made.

Also, 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. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected. Please notify this office in writing within fifteen (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 these violations, or similar violations, 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 an English translation of documentation not in English to facilitate our review.

Your response should be sent to: Ronald Swann, Chief: Dental, Ear, Nose, Throat, and Ophthalmic Devices Branch, 9200 Corporate Blvd., Rockville, MD 20850. If you have any questions about the content of this letter please contact Mr. Swann at,(240) 276-0115.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations 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 violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely yours,

/S/

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