TYTEX SLOVAKIA S.R.O. 6/12/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993-0002
June 12, 2013
VIA UNITED PARCEL SERVICE
Steen A. Henriksen
Vice President of Operations
Tytex Slovakia S.R.O.
Slovakia (Slovak Republic)
Dear Mr. Henriksen:
During an inspection of your firm located in Humenne, Slovakia, on January 21 through January 24, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Safehip AirX Textile Hip Protector devices. 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 Safehip AirX Textile Hip Protector 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 Kim Remin Rasmussen, Director of Q&E, dated February 13, 2013, 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 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 reasonably 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, Complaint (b)(4) describes an event where a (b)(4). The information included for the complaint reasonably suggests that the device may have caused or contributed to a reportable serious injury. However, a medical device report (MDR) was not submitted to FDA within 30 calendar days of becoming aware of the reportable event.
We reviewed your firm’s response and conclude that it is not adequate. Your firm failed to consider if the reported injury was or may have been attributed to your firm’s device or if your firm’s device was or may have been a factor in the reported injury, including events occurring as a result of user error.
2. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing the MDR procedure titled, Medical Device Reporting, WIP 2.4.1, Version 1.2, dated January 13, 2013, the following issues were noted:
a. The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, the procedure omits the definition of “malfunction,” “MDR reportable event” and “remedial action” found in 21 CFR 803.3. The exclusion of these terms may lead your firm to make an incorrect reportability decision when evaluating complaints that may meet the criteria for reporting under 21 CFR 803.50(a).
b. The procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example, the procedure does not have instructions for conducting a complete investigation of each event and evaluating the cause of the event.
c. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports. For example, the procedure does not have instructions for how to obtain and complete the FDA 3500A form. Additionally, the procedure does not state that the MDR reports should be submitted to: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s revised MDR procedure titled, Medical Device Reporting,WIP 2.4.1, Version 1.3 dated February 12, 2013,does not establish internal systems that provide for timely transmission of complete medical device reports. Additionally, the revised procedure failed to address item 2c.
If your firm wishes to submit MDR reports via electronic submission, it can follow the directions stated at the following URL: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the MDR Policy Branch at 301-796-6670 or by email at ReportabilityReviewTeam@fda.hhs.gov
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 a nonconformance with regards to section 501(h) of the Act,21 U.S.C. § 351(h), which is a deficiency 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. This nonconformance includes, but is not limited to, the following:
Failure to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example, the manufacturing test records dated October 20, 2012, for the Safehip devices specific to Lot (b)(4) did not meet the (b)(4) specification. The tested article was outside of the acceptance criteria of (b)(4) with a result of (b)(4). However, Lot (b)(4) was accepted for release. Additionally, the checklist used for reviewing the final acceptance and determining release of the devices did not include the final testing for (b)(4) specification requirements.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not address whether your firm has established an acceptable specification range used in the final acceptance testing of the device. Additionally, the response did not indicate the maximum (b)(4) the device can have before it affects the safety of the device.
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 Case # 395556) when replying. If you have any questions about the contents of this letter, please contact: Debra E. Demeritt at telephone 301-796-5770 or fax 301-847-8137.
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