Inspections, Compliance, Enforcement, and Criminal Investigations
Nouritress Hair Products, LLC 4/25/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Atlanta District Office|
60 Eighth Street N.E.
Atlanta, GA 30309
April 25, 2013
Ms. DeShawn Bullard
NouriTress Hair Products
305 Etowah Trace #108
Fayetteville, Georgia 30214
Ref: OIR: COR12000531
Dear Ms. Bullard:
During an inspection of your firm located in Fayetteville, Georgia, on November 2, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm imports and manufactures the NouriLaser laser hair comb. 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 any function of the body. Furthermore, under section 531 of the Act, 21 U.S.C. §360hh (3), the term “manufacturer” means any person engaged in the business of manufacturing, assembling, or importing of electronic products.
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:
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 has no design controls.
2. 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). Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications. Where process controls are needed they shall include:
(a) Documented instructions, standard operating procedures (SOP's), and methods that define and control the manner of production;
(b) Monitoring and control of process parameters and component and device characteristics during production;
(c) Compliance with specified reference standards or codes;
(d) The approval of processes and process equipment; and
(e) Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples.
For example, your firm has no process controls such as documented instructions, labeling procedures, incoming and finished product inspection and testing, or shipping records for 5 years.
3. Failure to establish and maintain procedures for implementing corrective and preventive action in a uniform and consistent manner, as required by 21 CFR 820.100(a). For example, your firm had no corrective and preventive action procedures.
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 has not established any standard operating procedures for reviewing and evaluating complaints.
5. Failure to establish a policy and objectives for, and commitment to, quality by management with executive responsibility, as required by 21 CFR 820.20(a). For example, you stated that you had no knowledge that the laser combs are devices and your firm has not established any standard operating procedures under the Quality System regulation.
Our inspection also revealed that the NouriLaser laser hair comb 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) 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). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)]
The kind of information that your firm needs to submit in order to obtain approval or clearance for the 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 the product may be legally marketed.
In addition, this letter is written to advise you of items of noncompliance with the Federal Food, Drug, and Cosmetic Act (Act), Subchapter C, Electronic Product Radiation Control, Section 538(a) [U.S.C. § 360oo(a)] as follows:
1. Failure to certify that the laser product complies with the applicable mandatory performance standard and that the firm has an adequate quality control testing program to assure that all certified units comply, as required by 21 CFR 1010.2. For example, the firm has no quality control inspection and testing program in place. Furthermore, the products are not certified by the (b)(4) manufacturer, (b)(4).
2. Failure to include manufacturer’s address, the country of origin, and date of manufacture on laser products imported into the U.S. for distribution, as required by 21 CFR 1010.3. For example, the laser products do not carry a compliant manufacturer’s identification label.
3. Failure to include an emission indicator on laser products, as required by 21 CFR 1040.10(f)(5). For example, the units examined had no emission indicator that provides a visible or audible signal during emission of accessible laser radiation in excess of the accessible emission limits of Class I.
4. Failure to include warning labels and safety information in user instructions for the laser products, as required by 21 CFR 1040.10(h)(1). For example, the user manual provided by the manufacturer (b)(4) contains no labels or radiation warnings.
5. Failure to include all required safety labels on laser products, including as applicable, Warning logotypes, aperture labels, and housing labels as required by 21 CFR 1040.10(g). For example, the units examined had no safety labels and Nouritress confirmed that the only label they attach is a name plate.
Section 538(a) of the Act, 21 U.S.C. § 360oo(a), prohibits any manufacturer from certifying or introducing into commerce electronic products which do not comply with an applicable standard. This section also prohibits any manufacturer from failing or refusing to establish and maintain required records or to submit required reports. Failure to respond to this letter may be considered to be a violation of section 538(a)(4) of the Act, 21 U.S.C. 360oo(a)(4). FDA is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in section 539 of the Act, 21 U.S.C. § 360pp. Persons who violate section 538 of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA. In cases where a foreign manufacturer fails to respond, penalties may be imposed upon importers.
You are required, under 21 CFR 1003.11(b), to immediately provide a written response to FDA with the number of referenced products which have been produced and the number of such products that have left the place of manufacture. In addition, if the product distribution was confined to specific geographical areas of the United States, please specify those areas. We request that you provide such a response no later than 15 days after receipt of this letter including supporting evidence/documentation with one of the options listed below:
1. Refutation ‑ Under 21 CFR 1003.11(a)(3), you may submit your views and evidence to establish that the alleged failures to comply do not exist.
2. Exemption Request ‑ Under 21 CFR 1003.30(a), you may request an exemption from user and dealer/distributor notification requirements in Under 21 CFR 1003.10(b). You must respond within 15 days from receipt of this letter to apply for such an exemption. If exempted from such notification, you are not required to correct the violative products (under 21 CFR 1004.1(a)). Your request must include the grounds upon which such exemption is requested (see 21 CFR 1003.30 and 1003.31) and the information required under 21 CFR 1003.20.
3. Purchaser Notification and Corrective Action ‑ If you neither refute the noncompliance nor request an exemption, then you must: (a) notify purchasers and dealers/distributors of the violative products as specified in 21 CFR 1003.10(b), and (b) submit a written corrective action plan (CAP) for approval showing how you will fulfill your obligation under 21 CFR 1004.1 to repair, replace, or refund the cost of the violative products.
a. Notification Letter ‑ Requirements for preparation of notification letters are prescribed in 21 CFR 1003.21 and 1003.22. A copy of the notification letter(s) sent to purchasers and dealers must also be sent to the FDA. It is recommended that you submit a draft of this letter to us for review.
b. Corrective Action Plan ‑ Instructions for preparation of a CAP may be found in 21 CFR 1004.2, 1004.3, or 1004.4. Such a plan must expeditiously correct the non-compliances and must be approved as set out in 21 CFR 1004.6.
If you request additional time to prepare your refutation, exemption request, notification letter, or CAP, you must provide the reasons for any delays and a reasonable target date for the full submission of your response. Be aware that if an acceptable CAP cannot be prepared promptly, you may be required to proceed with interim notification to affected persons as required by 21 CFR 1003.11(c) and 1003.21. Therefore, you are encouraged to immediately begin your preparation of accurate user location lists.
The following failures to comply with the regulations regarding reports and record keeping (and/or imports) were observed:
1. Failure to submit required Product reports on laser products imported into the U.S. for distribution, as required by 21 CFR 1002.10. For example, CDRH has no record of laser product reports from either Nouritress or the (b)(4) manufacturer, (b)(4), and Nouritress management was not aware of the regulations or reporting responsibility.
2. Failure to submit required Annual reports on laser products imported into the U.S. for distribution, as required by 21 CFR 1002.13. For example, CDRH has no record of laser annual reports from either Nouritress or the (b)(4) manufacturer, (b)(4), and Nouritress management was not aware of the regulations or reporting responsibility.
Additionally, under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2012.
Therefore all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. 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 award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations 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, 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.
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.
Your response should be sent to: Derek Price, Compliance Officer, Atlanta District Office, Food and Drug Administration, 60 Eight Street NE, Atlanta, Georgia 30309. You are also requested to send a copy of your response to: Chief, Magnetic Resonance and Electronic Products Branch, Division of Radiological Health, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, 10903 New Hampshire Ave., WO66-G609, Silver Spring, Maryland 20993-0002. Refer to the Unique Identification Number CMS case # 395326 and COR12000531 when replying. If you have further questions on these requirements, please contact Derek Price at the FDA Atlanta District Office at 404-253-2277 or Cory Tylka of the Magnetic Resonance and Electronic Products Branch at CDRH, at (301) 796-5869, or by email at: Corinne.email@example.com.
John R. Gridley
Atlanta District Office