- Somatex Medical Technologies GmbH
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 66
JAN 29, 2015
VIA UNITED PARCEL SERVICE
Somatex Medical Technologies GmbH
Rheinstrasse 7 d
Dear Mr. Kniep:
During an inspection of your firm located at Rheinstrasse 7 d, Teltow, Germany, on October 13, 2014, through October 16, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the TUMARK Flex for Mammotome and biopsy system. 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 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 in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21 , Code of Federal Regulations (CFR), Part 820.
We received a response from Christopher Hansche, Quality Manager, dated November 4, 2014, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations, which was issued to your firm. 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 establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm's corrective and preventive action (CAPA) procedure, (b)(4), Rev. 02, dated October 06, 2014, does not:
a. Include the requirement for analyzing sources of quality data to identify existing and potential causes of nonconforming product or other quality problems.
b. Define that appropriate statistical methodology will be employed where necessary to detect recurring quality problems.
c. Include the requirements for verifying or validating the corrective and preventive action to ensure that such action does not adversely affect the finished device.
d. Ensure that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems.
We reviewed your firm's response and conclude that it is not adequate. Your firm revised its CAPA procedure. However, your firm did not conduct a retrospective review of quality data and CAPA reports to ensure compliance with the revised CAPA procedure.
2. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example:
a. Your firm's design validation procedure, (b)(4), dated April 20, 2005, used during the validation of the Tum ark Flex for Mammotome IIG, does not:
i. State that the design validation will be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents.
ii. State that the design validation will include testing of production units under actual or simulated use conditions.
iii. Establish validation acceptance criteria.
b. Your firm's design validation for Tumark Flex devices was not conducted on the initial production units and under actual simulated conditions. In addition, your firm has not established validation acceptance criteria for the Tumark Flex devices.
We reviewed your firm's response and conclude that it is not adequate. Your firm plans to revise the design validation procedure and train personnel on the revised procedure. However, your firm did not conduct a retrospective review of design validation records for all devices to ensure that the design validations were conducted in accordance with the revised procedure.
3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm's supplier audit procedure requires suppliers to be audited at least every three years, and every two years if quality issues are identified. However, your firm has not conducted audits for at least three years for major component suppliers of Tumark Flex devices.
We reviewed your firm's response and conclude that it is not adequate. Your firm performed a gap analysis for the missing supplier audits, trained personnel and completed audits of critical suppliers. However, your firm did not address what was covered in the audits. Your firm did not provide evidence, such as an audit schedule or audit completion dates, to ensure that the audits were performed.
4. Failure to establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed, as required by 21 CFR 820.250(b). For example:
a. Your firm has not established valid statistical rationale for sample size for incoming raw material.
b. Your firm's manufacturing instruction for Tumark Flex requires (b)(4). However, this sample size was not established based on valid statistical rationale.
We reviewed your firm's response and conclude that it is not adequate. Your firm plans to revise its procedure to meet the requirements of ISO 2859, Sampling Procedures for Inspection by Attributes. However, you firm did not provide the revised procedure. In addition, your firm did not conduct a retrospective review of acceptance records to determine if the sampling plans were appropriate and initiate corrective actions where appropriate.
5. Failure to establish procedures for quality audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, your firm's internal quality audit procedure does not:
a. Ensure that individuals who conduct quality audits do not have direct responsibility for the matters being audited.
b. Identify that the quality systems regulations need to be audited by the individuals conducting the audits.
We reviewed your firm's response and conclude that it is not adequate. Your firm revised the internal quality audit procedure. However, your firm did not provide the revised procedure and personnel training records on the revised procedure. Your firm did not conduct a retrospective review of quality audits to ensure that the audits were performed in accordance with the revised procedure.
Our inspection also revealed that your firm's 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 (MDR). Significant violations include, but are not limited to, the following:
6. Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm's MDR procedure, Medical Device Reporting (b)(4), dated October 10, 2014, does not:
a. Establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, there are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms "become aware," "caused or contributed," "MDR reportable event," and "serious injury," and the definition for the term "reasonably suggests," found in 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
b. Establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting in accordance with 21 CFR 803.17. For example:
i. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
ii. There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
c. Establish internal systems that provide for timely transmission of complete medical device reports. Specifically, your firm's procedure does not address the circumstances under which your firm must submit supplemental or follow-up reports and the requirements for such reports.
d. Describe how your firm will address documentation and record-keeping requirements, including:
i. Documentation of adverse event related information maintained as MDR event files.
ii. Information that was evaluated to determine if an event was reportable.
iii. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
iv. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
We reviewed your firm's response and conclude that it is not adequate. Your firm revised its MDR procedure. However, your firm's revised procedure omits the definition of the term "reasonably suggests," found in 21 CFR 803.20(c)(1).
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
Given the serious nature of the violations of the Act, the devices manufactured by your firm, including the TUMARK Flex for Mammotome and biopsy system, 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 is taking steps to refuse entry of these devices into the United States, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you regarding the adequacy of your firm's response and the need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, U.S. federal agencies may be advised of the issuance of 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.
Please notify this office in writing, within fifteen business days from the date you receive this letter, of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your firm's response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #444474 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch at telephone +1 (301) 796-5587, or fax +1 (301) 847-8139.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the lnspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm 's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and
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