- Vibracare 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
Silver Spring, MD 20993
APR 17, 2015
VIA UNITED PARCEL SERVICE
Mr. Peter Peschel
Dear Mr. Peschel:
During an inspection of your firm located in Bremen, Germany, on December 15, 2014, through December 18, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures electric-powered percussive vests. 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 Mr. Erwin Dreyer, General Manager/COO, dated January 9, 2015, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional 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 document corrective and preventive action activities and their results, as required by 21 CFR 820.100(a).
For example, your firm’s corrective and preventive action (CAPA) procedure does not require verification or validation of the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.
Additionally, your firm’s procedure does not require all CAPA activities, and their results, to be documented.
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will update its CAPA procedures to ensure appropriate documentation of CAPA activities to include verification or validation of the effectiveness of the actions. However, your firm did not indicate if it plans to retrospectively evaluate CAPAs for similar deficiencies.
2. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example:
a. Your firm’s design change procedure does not require your firm to evaluate design changes to identify and perform design control activities, such as validation, verification, review, and approval, necessary to control the design changes.
b. A design change was made to connector cable (b)(4) to address multiple complaints of inoperable or malfunctioning devices; however, the design change was not reviewed or approved prior to implementation.
The adequacy of your firm’s response cannot be determined at this time. Your firm indicated that it will review all design changes to the device since the date of the 510(k) clearance and will update documentation in the design history file. Your firm also indicated that it will review and update supplier agreements to ensure your firm is notified prior to suppliers implementing design changes. You stated in your response that you would provide evidence of implementation within six months.
3. Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development, as required by 21 CFR 820.30(e).
For example, design reviews were not performed for the electric-powered percussive vest.
The adequacy of your firm’s response cannot be determined at this time. Your firm indicated that it will conduct a formal design review of the AffloVest device and update documentation in the design history file. You stated in your response that you would provide evidence of implementation within six months.
Our inspection also revealed that the AffloVestis 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 regarding the devices that is required by or under Section 519 of the Act, 21U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant deviations include, but are not limited to:
4. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, during the inspection, your firm’s management acknowledged that Oxycare/ Vibracare does not have an MDR procedure.
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it will develop an MDR procedure within 6 months. Without this documentation, FDA cannot make an assessment with respect to adequacy. Please submit a copy of your firm’s MDR procedure for review.
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: 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 Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
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 action (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. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
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 # 450437 when replying.If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at +1 (301) 796-5587 (telephone) or +1 (301) 847-8136 (fax).
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.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and