Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
May 26, 2011
VIA UPS EXPRESS
Mr. Vincent J. Leroy
VIPAMAT Technologie S.a.R.L.
Z.A. La Vraie Croix
Dear Mr. Leroy:
During an inspection of your firm located in Ploemeur, France, on January 24, 2011, through January 27, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the HIPPOCAMPE Special Grade Wheelchair. 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 are intended 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of the device, as required by 21 CFR 820.30(a).
For example, your firm has not established and maintained design control procedures for its Class II device.
2. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes prior to implementation, as required by 21 CFR 820.30(i).
For example, the seat material of your wheelchair exceeded a flammability rating limit set by the French government for reimbursement. Your firm changed the seat material without a formal process to document the design change.
3. Failure to document the results of a design review, including identification of the design, the date, and the individuals performing the review, in the design history file (the DHF), as required by 21 CFR 820.30(e).
For example, your firm documented the design inputs for the HIPPOCAMPE Special Use Wheelchair, but did not have the appropriate review and approval by a designated individual.
4. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a).
For example, your firm has not established and maintained procedures for CAPA. Although your firm conducted corrective actions, as a result of identified nonconformances, and documented these corrective actions, these actions were not conducted according to any established CAPA procedures.
5. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example, although your firm receives and documents complaints, it does not have formal procedures for documenting, reviewing, and evaluating complaints, and does not identify a designated unit for these activities.
6. Failure to establish and maintain procedures for changes to a specification, method, process, or procedure, as required by 21 CFR 820.70(b).
For example, your firm has not established procedures for changes in production processes. When a nonconformance was identified with the drill hole in the headrest, your firm made changes to the manufacturing process (e.g., increased drill bit diameter, change drill bit (b)(4). However, these actions were not undertaken according to any written procedures and none of these activities were documented.
7. Failure to establish and maintain procedures for rework of nonconforming product, to include retesting and reevaluation of nonconforming product after rework, to ensure that the product meets its current approved specifications, and to assure that the determination that the rework and reevaluation activities, including a determination of any adverse effect on the rework upon the product, is documented in the device history record (DHR), as required by 21 CFR 820.90(b)(2).
For example, when a nonconformance is identified by your firm, occasionally rework is performed; however, no procedures exist for rework and rework activities are not documented.
8. Failure to establish and maintain adequate procedures for finished device acceptance, as required by 21 CFR 820.80(d).
For example, although your firm has established written procedures for finished device acceptance, your firm has not established written procedures for final inspection of optional/separate device accessories produced by your firm (e.g., replacement arm rest, head rest).
9. Failure to establish and maintain procedures for the control of all applicable documents, as required by 21 CFR 820.40.
For example, modifications to procedures, specifications, and other documents were identified during the inspection; however, your firm neither has procedures for the review and approval prior to implementation, nor controls to assure that obsolete documents are appropriately removed or not used.
10. Failure to establish and maintain adequate procedures for quality audits, as required by 21 CFR 820.22.
For example, your firm has not established and maintained procedures requiring the performance of quality audits at defined intervals. Quality audits have not been performed since your firm was established in June 2002.
11. Failure to establish and maintain procedures for management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR Part 820 and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c).
For example, your firm has not established procedures for conducting management reviews.
Our inspection also revealed that your HIPPOCAMPE Special Grade Wheelchair 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 (MDR) regulation. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
During the inspection, your firm acknowledged that you were not aware of the requirements set forth in 21 CFR Part 803 and, therefore, you have not developed, maintained, and implemented written MDR procedures.
A follow-up inspection will be required to assure that corrections and/or corrective actions are adequate.
U.S. federal agencies are advised of the issuance of all 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 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your 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. 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to Case #180412 when replying. If you have any questions about the content of this letter please contact: Mr. Matthew Krueger at (301) 796-5585 or by facsimile at (301) 847-8139.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and Radiological Health