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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Madespa S.A. 10/2/08

   

hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
   

 

OCT 2 2008


WARNING LETTER

 

VIA FEDERAL EXPRESS {AND FACSIMILE}


Mr. Jose Pace Dova
Managing Director
Madespa S.A.
Rio Jarama, 120
Toledo, Spain, 45007


Dear Mr. Dova:


During an inspection of your firm located in Toledo, Spain, on April 21, 2008, through April 24, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures dental amalgam, dental composites, dental adhesives, etching gel, base metal alloy, dental amalgam capsule, resin coating material, and plastic instruments, which are imported or offered for import to any State or Territory of the United States, including the Commonwealth of Puerto Rico. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 United States Code (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. This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not inconformity with the Act's Current Good Manufacturing Practice (CGMP) requirement of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following:

 

1. Failure to establish and maintain procedures to ensure that formal documented reviews of the designs are planned and conducted at appropriate stages of the devices' design development, as required by 21 C.F.R. §820.30(e).

For example, your firm's (b)(4) called (b)(4) dated May 29, 2007, did not define and document (either in writing or electronically) procedures to ensure that both formal documented reviews of the devices' designs are planned and conducted, and participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual without direct responsibility for the design stage being reviewed. 

2. Failure to establish and maintain procedures to ensure that the devices' design are correctly translated into production specifications, as required by 21 C.F.R §820.30(h).


For example, your firm's (b)(4) called (b)(4), dated May 29, 2007, did not define and document (either in writing or electronically) procedures to ensure that the devices' designs are correctly translated into production specifications. 


3. Failure to establish and maintain procedures for identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 C.F.R. §820.30(i). 


For example, your firm's (b)(4) called:(b)(4) dated (b)(4) did not define and document (either in writing or electronically) procedures for the documentation, validation or where appropriate verification, review, and approval of design changes before their implementation. 


4. Failure to evaluate complaints to determine whether the complaint represents event that the manufacturer is required to report to FDA under section 519(a), 21 U.S.C. §360i(a). 21 C.F.R. §820.198(a)(3). 


For example, your firm's complaint handling procedures have not been and documented (in writing or electronically) to ensure that all received complaints are reviewed and evaluated to determine whether the be filed as a Medical Device Report under part 519(a), 21 U.S.C. §360i(a). Specifically, your firm's (b)(4), dated February 7, 2007, does not include a process or a formally designated unit for evaluating complaints to determine whether your devices may have caused or contributed to a death or serious injury, or have malfunctioned and likely would cause or contribute to a death or serious injury if the malfunction recurred, in which case the Act requires you to report the adverse event to FDA, under 21 C.F.R. part 803. 

 

5. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 C.F.R. §820.70(a). Document instructions, standard operating procedures (SOPs), and methods that define and control the manner of production, as required by 21 C.F.R. §820.70(a)(1). 


For example, your firm failed to follow your own procedure, (b)(4) dated (b)(4) Of the (b)(4) Device History Records reviewed for the (b)(4) FDA determined that the required density test was not performed for (b)(4) lots and the pH test had not been conducted for (b)(4) product lots. Also your firm failed to follow your written (b)(4)


6. Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented, as required by 21 C.F.R. §820.5O(a)(1).  

For example, your firm failed to follow your written (b)(4), dated (b)(4)  In addition, your firm lacks show that supplier audits were conducted from (b)(4) which violates FDA's mandate that your firm certify in writing, upon FDA's request, that supplier audits have been performed and documented, under 21 C.F.R. §820.180(c).


7. Failure to establish procedures for identifying training needs and to ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 C.F.R. §820.25(b). The training must be documented. 21 C.F.R. §820.25(b).


For example, your firm's (b)(4), demonstrated that your firm's production personnel did not have the necessary (b)(4) to ensure competent performance of their assigned tasks. Specifically, there were no records to indicate that employees involved in quality and production activities had received CGMP (b)(4)

8. Failure to establish and maintain device history records (DHRs) that include or refer to the location of, the primary identification label and labeling used for each production unit, as required by 21 C.F.R. §820.184(e). 

 

For example, your firm's DHRs did not include the primary identification label and labeling for each device that your firm manufactures. Specifically, of the twelve reviewed Device History Records dating from (b)(4) DHRs lacked the primary identification label and labeling for the (b)(4)

9. Failure to maintain records of changes to documents, under 21 C.F.R. §820.40(b). Records of changes shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective, as required by 21 C.F.R. §820.40(b).


For example, your firm's processing records and DHRs contained errors that were not crossed out and initialed by the employee responsible for performing the task.


Our inspection also revealed that the dental amalgam, dental composites, dental adhesives, and etching gel are adulterated under section 501 (f)(1)(B) of the Act, 21 U.S.C. §35 1(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). The device is also misbranded under section 502(0) of the Act, 21 U.S.C. §352(0), because you did not notify the agency of your intent to introduce the device into commercial distribution within any State or Territory of the United States, including the Commonwealth of Puerto Rico, 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 FDA. 21 C.F.R. §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. FDA will evaluate the information you submit and decide whether your product may be legally marketed within any State or Territory of the United States, including the Commonwealth of Puerto Rico.


Given the serious nature of the violations of the Act, the dental amalgam, dental composites, dental adhesives, and etching gel manufactured by your firm, are subject to refusal of admission into any State or Territory of the United States, including the Commonwealth of Puerto Rico, under section 801 (a) of the Act, 21 U.S.C. §381(a), because the devices are misbranded. 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 Warning 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 they consider awarding contracts. Additionally, premarket approval applications for Class ill 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 the person listed below in writing within fifteen (15) working days from the date you receive this Warning Letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these or similar violations from recurring. Include documentation of the corrective actions you have taken. If corrective action cannot be completed within 15 working days from the date you receive this Warning Letter, please state the reason for the delay and include a timetable for implementation of the corrections. Please provide an English translation of any document not in English, to help our review.


Your response should be sent to: Ronald L. Swann, Chief, Dental, Ear, Nose, Throat, and Ophthalmic Devices Branch, Rockville, Maryland, 20850, United States. If you have any questions about the content of this Warning Letter, please contact Ronald at 1-240-276-0115 (office) or 1-240-276-0114 (fax).


Finally, be advised that this Warning Letter is not intended to be a complete list of the violations at your facility. It is your responsibility to ensure compliance with the applicable laws and regulations administered by FDA. The specific violations noted in this Warning 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 and facility into compliance with the Act.

 

Sincerely yours,

 

/S/


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