R82 A/S 10/18/13
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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
October 18, 2013
VIA UNITED PARCEL SERVICE
Mr. Erik Nissen, CEO
Dear Mr. Nissen:
During an inspection of your firm located in Gedved, Denmark, on June 3, 2013, through June 7, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Cougar wheelchair, the Panther wheelchair, the Cheetah wheelchair, the Flamingo wheelchair, the Stingray mechanical chair, the Tiger 2000 mechanical chair, the Serval mechanical chair, the Wombat chair, the Nandu chair, the Swan bath chair, the Manatee bath chair, the Rabbit mobile standing frame, the Buffalo standing frame, the Gazelle standing frame, and the Toucan standing frame. 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 responses from Kent Aatofte Rasmussen, Quality Manager, dated June 28, 2013, and September 6, 2013, 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 these responses 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 to include requirements for verifying or validating corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).
For example, the QA Procedure 40-10-015, for Corrective and Preventive Actions (CAPA), Revision 8, dated May 18, 2013, states that, for corrective and preventive actions, “the selected solution must be verified that it solved the problem” so “test and performance evaluation must be performed.” Your firm failed to verify that implemented solutions solved the problems for several CAPAs, including #10686, dated April 5, 2013, and #10655, dated February 18, 2013. These CAPAs demonstrate that your firm took steps to correct the underlying problems, but did not document test results to verify that the changes were effective, or verify or validate that the changes did not affect the finished device.
We reviewed your firm’s response and conclude that it is not adequate because, although your firm has listed standards and procedures that it has followed, your firm has not indicated that it completed verification or validation testing of its previous CAPAs to ensure that the actions are effective and do not adversely affect the finished device.
2. Failure to review and evaluate all complaints to determine whether an investigation is necessary and, when no investigation is made, to maintain a record that includes the reason that no investigation was made and the name of the individual responsible for the decision not to investigate, as required by 21 CFR 820.198(b).
For example, the following complaints were not reviewed and evaluated to determine whether investigations were necessary, and there is no record that includes the reasons why no investigations were made and the name of the individual responsible for the decision not to investigate: 10.942, 10.983., 9.967, 8.239, and 7.618.
3. 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, the QA Procedure 30-10-002, Design and Development, dated May 30, 2013, includes requirements for “elaboration of design input specification,” “design output verification,” and “design transfer” under section “4. Procedure.” The QA Procedure 30-10-102, Design History File (DHF), dated May 28, 2013, also references the following documents in section “5. Reference”: 30-10-104 User Requirement Specification, 30-30-204 Design Input Specification, and 30-30-404 Validation Plan. Your firm was unable to provide the FDA investigator documents for the following requirements: a project plan, user requirement specifications, design inputs, design outputs, design review, design verification, design validation, or design transfer.
The adequacy of your firm’s response cannot be determined at this time because your firm did not submit the Rabbit DHF for FDA review.
4. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a).
For example, your firm could not provide to the FDA investigator any methods that develop, conduct, control, and monitor production processes to ensure that the Rabbit device conforms to its specifications.
The adequacy of your firm’s response cannot be determined at this time because the assembly instruction did not include an English translation.
5. 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, according to QA Procedure 70-10-019, Supplier Segmentation, dated May 29, 2013, your firm evaluates a supplier based on purchase volume and its possibility of supplier replacement. Your firm does not evaluate a supplier based on the supplier’s ability to meet specified requirements including quality requirements.
6. Failure to maintain device master records (DMRs) and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181.
For example, your firm was unable to provide the FDA investigator with the DMR for the Rabbit device that includes or refers to the locations of the device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and installation, maintenance, and servicing procedures and methods.
Given the serious nature of the violations of the Act, the Cougar wheelchair, the Panther wheelchair, the Cheetah wheelchair, the Flamingo wheelchair, the Stingray mechanical chair, the Tiger 2000 mechanical chair, the Serval mechanical chair, the Wombat chair, the Nandu chair, the Swan bath chair, the Manatee bath chair, the Rabbit mobile standing frame, the Buffalo standing frame, the Gazelle standing frame, and the Toucan standing frame 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 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 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, 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. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices 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 (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. 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 Operations Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #412111 when replying. If you have any questions about the contents of this letter, please contact: Matthew Krueger at 301-796-5585 or by fax at 301-847-8128.
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