|Company:||Contract Medical International Spol. S.o.r.|
|Subject:||Medical Device Reporting Regulation/Adulterated/Misbranded|
|Issuer:||Center for Devices and Radiological Health|
|Issued:||Dec. 12, 2012||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
DEC 12, 2012
VIA UNITED PARCEL SERVICE
Contract Medical International Spol. S.o.r.
Dear Mr. Kloboucnik:
During an inspection of your firm located in Hradec Kralove, Czech Republic on August 7, 2012, through August 9, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Biotronik Fortress Introducer Sheath 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.
Our inspection revealed that the Biotronik Fortress Introducer Sheath System 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. We received a response from you dated August 16, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that 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 of your firm to adequately develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17(a)(1). After reviewing your firm’s procedure titled “Contract Medical International Medical Device Reporting & Related Recall” MFB-004 Rev: 0 Issue Date: 03.08.2012, the following issues were noted:
a. Your firm’s procedure titled Contract Medical International Medical Device Reporting & Related Recall MFB-004 Rev: 0 Issue Date: 03.08.2012 does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements.
b. MFB-004, Rev: 0 does not contain definitions of what your firm will consider to be reportable events under 21 CFR Part 803. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions based on 21 CFR 803.3 for the terms "become aware," "caused or contributed," "malfunction," "MDR reportable event," "remedial action," and "serious injury," and definitions for the terms "reasonably known" and "reasonably suggests," found respectively in 21 CFR 803.50(b) and 803.20(c)(1).
2. Failure to report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that responsibly suggests that a device that it markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example: Complaints PC11020 and PC11026 describe events where the physicians experienced difficulties either advancing or withdrawing the sheath due to scar tissue, and in both cases the sheath broke into pieces when the physicians tried to remove the sheath. The pieces remained in the patient and required surgical intervention to remove the broken pieces from the patient’s vessels. The definition of “caused or contributed” in 21 CFR 803.3 means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury. Given the nature and use of this device, we believe that these events are reportable as serious injuries. Therefore, an MDR should have been submitted for each of the referenced complaints within the required 30 calendar day timeframe. Your firm stated as its rationale for not reporting the events described in complaints PC11020 and PC11026 that “the incident occurred not in US market and investigation did not prove that the device is a contributory cause of accident.” Your firm should be aware that if an event occurs in a foreign country, it may be reportable under the MDR regulation, if the event involves a device that is similar to a device that has been cleared or approved for marketing in the U.S.
We reviewed your firm’s response dated August 16, 2012, and concluded that the adequacy of your firm’s response cannot be determined at this time. Although FDA received the MDR for the referenced complaints and your firm stated that its MDR procedures would be revised, your firm did not include in its response documentation or evidence of its revised and implemented procedures. Without this documentation in hand, FDA cannot make an assessment with respect to adequacy.
Given the serious nature of the violations of the Act, Biotronik Fortress Introducer Sheath System 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, 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 if your firm’s response appears to be adequate, and we may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, 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 awarding of contracts.
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, as well as 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 (including any systemic corrective actions) 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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
Failure to adequately establish procedures for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finish device as required by 820.100(a)(4). For example, document no. QA-004, Rev. 3, dated August 19, 2011, Measurement, Analysis and Improvement, does not adequately specify the requirements for verifying and validating corrective and preventive action (CAPA) activities. The procedure states on page 5 that “the check of effectiveness of completed CAPA project is specified by CAPA Review Board.” The procedure requires for an effectiveness check to be documented on CAPA Project Form QA-F004, but does not describe how to conduct or determine whether an effectiveness check is to be verified or validated. Further, the section for check of effectiveness for CAPA document no. CAPA-022, closed on June 15, 2010, titled: “Improve Control and Quality of MPH” states “no direct effectiveness check required.” The CAPA specifies that an effectiveness check is not applicable. Thus, the effectiveness check was not conducted.
We reviewed your firm’s response dated August 16, 2012, and concluded that your firm’s response is not adequate. Your firm has provided a plan to address the observation which includes a review of the effectiveness of all CAPAs closed out in 2011 and 2012. Additionally, your firm proposes to revise procedure QA-004, Measurement, Analysis and Improvement, to add descriptions of the effectiveness evaluation of the corrective action and adverse events. However, your firm has not provided documentation of the implementation of these changes.
Your firm’s response to this letter should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to the Unique Identification Number CMS #378138. If you have any questions about the contents of this letter, please contact: Daniel Walter at (301) 796-5587 or by fax at (301) 847-8138.
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 Inspectional 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.
Steven D. Silverman
Office of Compliance
Center for Devices and Radiological Health