- Aussimed Ltd
- 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|
Silver Spring, MD 20993
MAR 3, 2016
VIA UNITED PARCEL SERVICE
CEO, Managing Director
Dear Mr. Rauer:
During an inspection of your firm located in Neuried, Germany,on November 2, 2015, through November 3, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures biofeedback 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.
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 you, dated November 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. Your firm’s response, dated December 30, 2015, to the Form FDA 483 (FDA 483) was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. The response will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter.
These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm failed to establish procedures for design control for the CyberScan device.
We reviewed your firm’s response and conclude that it is not adequate. The response does not include documentation that demonstrates established design controls.
2. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). For example, (b)(4) CyberScan device. Your firm did not evaluate (b)(4) a potential supplier on the basis of the ability to meet specified requirements. Additionally, your firm’s record of acceptable suppliers does not include (b)(4).
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response does not include a summary or copies, in English, of a revised supplier control procedure and an updated record of acceptable suppliers. Also, your firm’s response does not include evaluations of suppliers, and definitions of the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, for three CAPAs, dated June 16, 2014, July 14, 2014, and July 15, 2014, your firm did not perform verification or validation of corrective actions.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response does not include a summary or copy, in English, of a revised CAPA/complaint handling procedure, which requires verification of corrective and preventive action effectiveness. Also, your firm’s response does not include a review of previous CAPAs, to ensure compliance to the revised procedure, and to ensure that CAPA effectiveness has been verified or validated where appropriate.
4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm’s complaint handling procedure, “VA Fehler + Korrekturen / complaints + corrective actions,” Rev 1, does not require:
a. Oral complaints to be documented upon receipt; and
b. Records of investigation to include the name, address, and phone number of the complainant.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response does not include a summary or copy, in English, of a revised CAPA/complaint handling procedure, which requires documentation of oral complaints and investigation of complaints.
5. Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit, are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR) and the requirements of 21 CFR Part 820, as required by 21 CFR 820.184. For example, your firm did not establish a procedure for DHRs. Additionally, the DHR did not include the primary identification label and labeling used for eleven devices.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response does not include a summary or copy, in English, of a revised DHR procedure. Also, your firm’s response does not include a review of previous DHRs, to ensure compliance to the revised procedure and 21 CFR 820.184.
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 responses 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 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Refer to CMS Case No. 490041 when replying. If you have any questions about the contents of this letter, please contact Daniel Walter, Chief, Foreign Enforcement Branch,
(email), or +1(240)402-4020 (telephone).
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.
Robin W. Newman
Office of Compliance
Center for Devices and Radiological Health
Nu Device Consulting LLC
210 Farmers Top
Murphy, North Carolina 28906