Inspections, Compliance, Enforcement, and Criminal Investigations
Stratec Medizintechnik Gmbh 10-Sep-08
Department of Health and Human Services
Public Health Service
Center for Devices and
September 10, 2008
VIA FEDERAL EXPRESS
Stratec Medizintechnik Gmbh
Durlacher Str. 35
Dear Mr. Schubert:
During an inspection of your firm located in Pforzheim, Germany on June 2, 2008, through June 5, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the XCT 2000 and 3000 bone densitometer. 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.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C, § 35l(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. On July 9, 2008, we received an undated response from your firm concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to adequately establish and maintain procedures for implementing corrective and preventive action by failing to adequately analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, and failing to utilize appropriate statistical methodology to detect recurring quality problems, as required by 21 CFR 820.100(a)(1). For example, Stratec Medizintchnik only analyzes telephone service requests from German companies. There is no analysis of other quality data such as telephone service requests from other countries, faxes or emailed service requests. Furthermore, the statistical methodology utilized to analyze the German telephone service reports was not adequate in that the data was not stratified by device type or year of production in order to provide the necessary evidence to support the conclusion that the XCT 900 component failures were due to old parts.
We have reviewed your response and have concluded that it is inadequate because the response is unclear and incomplete. It consists of a printout from a computerized database entitled (b)(4) written in German. The response does not contain a revised Corrective and Preventive Action (CAPA) procedure nor does it explain, in English, the nature of the change contained in the computer printout addressing how and/or why the change adequately ensures a functioning CAPA system. The response also lacks evidence of the implementation of the change, including evidence of training appropriate personnel on the change.
2. Failure to adequately maintain complaint files, and adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints as required by 21 CFR 820.198(a). For example Stratec Medizinintrechnik failed to:
a. Maintain complaint files for customer reports of device malfunction issues for the bone densitometer devices, models XCT 2000 and 3000.
b. Obtain device complaint/malfunction information from the U.S. distributor of the XCT 2000 and 3000 devices.
We have reviewed your response and have concluded that it is inadequate because the response is unclear and incomplete. It consists of a printout from a computerized database entitled Extract from report list (b)(4) written in German. The response lacks a revised complaint handling system procedure and an explanation, in English, of the nature of the change contained in the computer printout addressing how and why the change adequately ensures a functioning complaint handling system. The response also lacks evidence of the implementation of the change, including evidence of training appropriate personnel on the change.
3. Failure to adequately document acceptance activities, as required by 21 CFR 820.80(e). For example:
a. Stratec Medizinitechnik Gmbh failed to adequately document the acceptance or rejection results for the (b)(4) functional testing of the amplifier printed circuit board used to make the Detector subassembly. More specifically, Stratec Medizintechnik's records show that between September 1, 2001 and January 1, 2004, no incoming acceptance testing data was recorded, and in 2004, the firm discontinued documenting the number of amplifiers tested which were acceptable, defective or reworked.
b. The printouts contained in the DHR derived from computer software used to calibrate and test the finished device do not include the name of individual or contain the signature of the individual who performed the test and evaluated the results.
We have reviewed your response to the example outlined in 3(a) and have concluded that it is inadequate because the response is unclear and incomplete. The response consists of two tables in German. One table is titled (with *) (b)(4)(b)(4)(b)(4). Furthermore there is no explanation, in English, as to how and/or why the change adequately ensures appropriate acceptance activities are performed and documented. The response contained no acceptance procedure to show adequate documentation of acceptance activities is required. The response also lacks evidence of the implementation of the change, including evidence of training appropriate personnel on the change.
We have reviewed your response to the example outlined in 3(b) and have concluded that it is inadequate because the response is unclear and incomplete. The response consists of several pages of revised procedures or quality records written in German. Specifically it consists of a single page of a procedure titled (b)(4)(b)(4) and printout titled (b)(4) This printout has a handwritten date of 26.06.08 next to a signature. However, there is no explanation, in English, for how to interpret these documents. Furthermore there is no evidence that personnel impacted by the change have been trained on any new procedure.
4. Failure to adequately ensure that calibration records for inspection, measurement and test equipment include equipment identification, calibration dates, the individual performing each calibration and the next calibration date, as required by 21 CFR 820.72(b)(2). For example:
a. On June 2, 3, and 4, 2008, a (b)(4) was observed in the production area for testing the voltage of various printed circuit boards. There was no identification on the (b)(4) to distinguish it from other (b)(4) and no date on the (b)(4) indicating when it was last calibrated.
b. Calibration records for (b)(4) are incomplete. The (b)(4) (b)(4) identified by Stratec Medizinitechnik personnel as (b)(4) does not contain any identifying marks showing it is voltage meter (b)(4) Furthermore, the records for voltage meter (b)(4) do not indicate whether or not the (b)(4) passed or failed the initial calibration.
c. The work instruction for (b)(4) identifies the use of the (b)(4) during final product testing of the bone densitometer devices, models XCT 2000 and XCT 3000. Each model utilizes a different (b)(4) The (b)(4) are labeled (b)(4) (b)(4)." One (b)(4) is labeled for use with the XCT 2000 model. No (b)(4) is labeled for use with the XCT 3000 model. These two are stored in a case containing (b)(4) for different calibration purposes, increasing the potential for mix-ups and mis-use.
We have reviewed your response and have concluded that it is inadequate because the response is unclear and incomplete. The response consists of several pages of revised procedures or quality records written in German. The pages submitted as a response to this deviation include:
o a table titled (b)(4)
o two different tables titled (b)(4)
o a single page of a procedure titled (b)(4)(b)(4)
o a single sheet that appears to be labels for (b)(4)
The response lacks an explanation, in English, of how and/or why the change adequately addresses the violation. The response also lacks evidence of the implementation of the change, including evidence of training appropriate personnel on the change.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 381(a)). 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 violation(s), or similar violation(s), 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. If the documentation is not in English, please provide a translation to facilitate our review.
Your response should be sent to:
Orthopedics, Physical Medicine and Anesthesiology Devices Branch (HFZ-343)
Division of Enforcement B
Office of Compliance
2094 Gaither Road
Rockville, MD 20850
If you have any questions about the content of this letter please contact: Ms. Erin Keith at (240) 276-0120 or firstname.lastname@example.org or fax at (240) 276-0129.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) 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(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and