Gexfix SA 5/15/13
| || |
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
May 15, 2013
VIA UNITED PARCEL SERVICE
Mr. Giuseppe Longo
CEO and President
Av. De La Praille
50 Carouge, CH-1227
Dear Mr. Longo:
During an inspection of your firm located in Carouge, Switzerland, on January 14, 2013, through January 16, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Gexfix External Fixation Systems. 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. These violations include, but are not limited to, the following:
- Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example:
a. The instructions for use list a cleaning and sterilization method; however, no testing was performed to support the instructions for use. The FDA investigator reviewed your firm’s design history file and the instructions for use indicated, “recommended approved,” for sterilization cycle times and temperatures. Your firm’s representatives indicated that the sterilization method is suggested and it is the customer’s responsibility to determine the correct sterilization. The investigator explained that sterilization is part of the design of the device and must have documentation that demonstrates it can be sterilized in a manner that does not affect the device function. Your firm did not have data to substantiate its suggested sterilization method.
b. The risks identified for the Gexfix External Fixation System have not been evaluated for mitigation. The FDA investigator reviewed your firm’s Dossier de Gestian des risques Fixateur externe for risk analysis. Your firm identified (b)(4) infection at the pin insertion as a risk; however, this risk was not included in the mitigation section of the document and no mitigation was identified. Additionally, not all listed mitigations have been implemented. The risk of infection due to failed sterilization was to be mitigated by performing sterilization validation; however, this was not performed.
- Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example: the acceptance procedure for incoming products was not implemented. The FDA investigator reviewed 10 of 11 Rapport de Controle Vis (incoming inspection reports) and noted that your firm failed to use the ISO 2859-1 sampling plan that was required by PRO-06 Procedure de Contole. Your firm’s representative indicated that a new procedure, PRO-06 Controle, Rev B, which uses (b)(4), was implemented. However, the investigator was unable to evaluate whether the new procedure corrected the issue.
- Failure to establish and maintain 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 acceptance activities for assembly parts are not completely documented. The FDA investigator noted that the manufacturing employees follow INS 21 Controles de Fin de Gamme, to perform final inspection and sign-off for release of the lot. However, the investigator reviewed 11 Nomenclature Records (finished device control document) and found 11 of 11 records had not documented the quality inspection sample number or the results.
- Failure to establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that, when changes occur, the sampling plans are reviewed and documented, as required by 21 CFR 820.250(b). For example: Procedure INS 21, Contoles de Fin de Gamme, Version A, used for acceptance of assembly pieces, required review of approximately (b)(4) of the pieces, but no more than (b)(4) devices. The FDA investigator indicated that there is no valid statistical rationale for this plan. Your firm’s representative changed the procedure to ISO 2958-1 and AQL 2.5 during the inspection. The investigator collected the new procedure, but was unable to evaluate the implementation.
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 action (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 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 396216 when replying. If you have any questions about the contents of this letter, please contact: Matthew C. Krueger at (301) 796-5585 or fax (301) 847-8438.
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