MEDICAMAT S.A. 4/19/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
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Silver Spring, MD 20993-0002
April 19, 2013
VIA UNITED PARCEL SERVICE
59, Avenue Augustin-Dumont
92240 Malakoff, France
Dear Mr. Devidal:
During an inspection of your firm located in Malakoff, France, on October 15, 2012, through October 16, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Punch-Hair-Matic-Suction Assisted Follicular Extraction & Re-implantation (S.A.F.E.R.) device. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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.
Our inspection revealed that the Punch-Hair-Matic- S.A.F.E.R. device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The Punch-Hair-Matic- S.A.F.E.R. device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
Specifically, a review of our records reveals that the Punch-Hair-Matic- S.A.F.E.R. device is registered and listed as a Class I device, exempt from section 510(k) of the Act, under 21 CFR 878.4800, manual surgical instrument for general use. The Punch-Hair-Matic- S.A.F.E.R. has a different intended use compared to legally‑marketed devices classified under 21 CFR 878.4800. Devices classified under this provision are intended to automate hair transplant for the surgical treatment of baldness. However, the Punch-Hair-Matic S.A.F.E.R device is indicated to treat the first stages of male and female diffuse hair loss and for thickening of the glabrous skin and eyebrow repair. Because the Punch-Hair-Matic- S.A.F.E.R. device has a different intended use than devices classified under 21 CFR 878.4800, it exceeds the limitations described in 21 CFR 878.9(a) and is not exempt from premarket notification.
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for its device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether your product may be legally marketed.
Given the serious nature of the violations of the Act, the Punch-Hair-Matic- S.A.F.E.R. device is subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that it appears to be adulterated. As a result, FDA is taking steps to refuse entry of these products 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, 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 awarding of contracts.
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, as well as 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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act, 21 U.S.C. § 351(h), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
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).
Specifically, your firm's Complaints and Corrective Actions Procedure, Reference #PRG007, Revision 5, requires complaints to be documented using form ENR002 (Record of Non-Conformity). However, your firm received a total of (b)(4) complaints in (b)(4) and (b)(4) of them were documented and processed using form ENR002 as required.
Your firm’s response to this observation appears to be adequate. Your firm has documented the previous complaints on form ENR002 (Record of Non-Conformity) and has submitted copies for FDA review.
Your firm’s response to this letter should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Room 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. When replying, refer to the unique identification number: CMS case # 391311). If you have any questions about the contents of this letter, please contact: LaShanda Long, General Surgery Devices Branch Chief at 301-796-5465or (fax) 301-847-8137.
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, Form 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
L.W. Ward & Associates, Inc.
4655 Kirkwood Court
Boulder, Colorado 80301