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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Apira Science, Inc. 4/17/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415 

 

WARNING LETTER
 
 
 
 
VIA UNITED PARCEL SERVICE                                                                                                                                     
SIGNATURE REQUIRED
 
 
April 17, 2012
                                                                                                                                                                                                                                                               WL   23-12
Mr. Nicholas J. Brox,                                                                                                                                                                         
President and CEO
Apira Science, Inc.
100 Bayview Circle, Suite 2200
Newport Beach, CA 92660
 
Dear Mr. Brox:
 
During an inspection of your firm located in Newport Beach, California on August 16, 2011 through September 29, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the iGrow Hair Rejuvenation System and the Revage 670 Laser System. 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 the iGrow Hair Rejuvenation System is 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, its 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 Todd A. Harrison and Michelle C. Jackson, Counsel to Apira Science, Inc. dated October 10, 2011 and October 11, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), Inspectional Observations, which was issued to your firm. 
 
We reviewed your firm’s responses, in relation to each of the noted violations, and conclude that they are not adequate. Each of your firm’s responses states that it does not believe that the iGrow is a device and does not need to comply with 21 CFR Part 820 Quality System Regulation. 
 
Your firm also submitted responses to the Form FDA 483 (FDA 483) dated November 14, 2011, November 30, 2011, December 31, 2011, January 31, 2012, February 28, 2012, and March 31, 2012, in which you discussed the CAPA’s that you have opened to address the observations identified in the 483 for the iGrow device. These responses were not reviewed because they were not received within fifteen business days of issuance. The responses may be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. 
 
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. For example:
 
a.    Your firm failed to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation, for the iGrow Hair Rejuvenation System, as required by 21 CFR 820.30(b). The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.
b.    Your firm failed to establish and maintain a design history file (DHF) for the iGrow Hair Rejuvenation System, as required by 21 CFR 820.30(j). The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of 21 CFR Part 820.
c.    Your firm failed to document the results from any design validation activities for the iGrow software, as required by 21 CFR 820.30(g). Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.
 
2.   Failure to maintain a device master record (DMR) and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181. The DMR for the device shall include, or refer to the location of, the following information: (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; (d) Packaging and labeling specifications, including methods and processes used; and (e) Installation, maintenance, and servicing procedures and methods.
 
For example, your firm has not maintained a DMR for the iGrow Hair Rejuvenation System. 
 
3.   Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented. 
 
      For example, procedures for acceptance of incoming product, the iGrow Hair Rejuvenation System, have not been established.
 
4.   Failure to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820.198(c). For example:
 
a.   A review of the complaints received by your firm show that your firm replaces the iGrow and refunds money without conducting an investigation. Your firm did not document that such investigations were not necessary. Examples of these complaints include the following:
 
i    Complaint # 11-001 stated there was no display on the LCD screen.
ii    Complaint # 11-069 stated that the LCD screen displays “unconnected,” and the screen is fuzzy with a line going across it. 
iii    Complaint # 11-020 stated that the remote pad and head for the iGrow were not communicating. 
iv    Complaint # 11-043 stated that the iGrow was beeping. 
v    Complaint # 11-024 stated that the screen was “fuzzy” and unconnected and the light does not turn on.
vi    Complaint # 11-038 stated that the iGrow kept shutting off and the treatment settings were sticking.
 
b.   Numerous returns and refunds were noted on the Inquiry/Complaint Log for dissatisfaction with the device because they did not work as intended, including complaints #11-023, #11-042, #11-045, #11-050, #11-051, #11-052, #11-056, #11-058, #11-064, #11-072, #11-075, #11-076, #11-077, #11-079, and #11-080. No investigation was conducted, and your firm did not document that such investigations were not necessary. 
 
5. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100. The procedures shall include requirements for, among other things: analyzing complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems; investigating the cause of nonconformities relating to product, processes, and the quality system; and identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems. All activities required under 21 CFR 820.100(a), and their results, shall be documented, under 21 CFR 820.100(b).
 
For example, your firm had no documentation to demonstrate that the complaints your firm received, including complaints of “fuzzy” screens, the unit shutting off, LCD lights not working, or beeping from the unit, were analyzed to identify existing or potential causes of nonconforming products or other quality problems. Additionally your firm replaces the iGrow without documenting whether an investigation was conducted to determine the cause of the nonconforming product.
 
6.    Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. 
 
      For example:
 
a.    Your firm failed to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services.
b.    Your firm failed to establish and maintain records of acceptable suppliers. Your firm’s approved supplier list states all suppliers are “grandfathered in.”
c.    Your firm failed to document the evaluation of potential suppliers on the basis of their ability to meet specified requirements, including quality requirements. Not all suppliers are on your firm’s approved supplier list.
 
7.   Failure to establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured to establish how the requirements for quality will be met, as required by 21 CFR 820.20(d). 
 
      For example, your quality plan does not define how the quality requirements will be met.
 
In addition, we reviewed your firm’s labeling for the iGrow Hair Rejuvenation System (iGrow) and the Revage 670 Laser System (Revage). According to the labeling for the iGrow:
 
  • “The lasers produce a wavelength of 655 to 670 nanometers that have been shown to increase cellular activity within the follicles. The LEDs, with their broader array of light energy, help provide complete scalp coverage. Effective and perfectly safe, this combination of red therapeutic light helps to rejuvenate the hair follicles” 
  • “Low Level Light Therapy (LLLT) stimulates cells. LLLT revitalization isn’t superficial. Cells absorb the low level light and become more active, this is known as photo-biostimulation.  . . . Cells then begin to repair and revitalize themselves, leading to thicker, fuller, healthier hair”
 
Your firm’s labeling for Revage states:
 
  • “[Revage] is effective in treating androgenetic alopecia and telogen effluvium"  
  • “nearly all patients with telogen effluvium report complete cessation of shedding”
  • “The Revage 670 uses a pure visible red light at 670 nm, the optimum wavelength and frequency to stimulate a dramatic increase in micro-circulation of blood supplies in the scalp. This increases cellular metabolism and promotes the repair of damaged cells and weakened hair follicles, leading to the cessation of hair loss and the stimulation of hair regrowth”
  • “This same principal (sic) is now applied in the Revage 670 in order to repair damaged blood vessels in the scalp by promoting neovascularization, thereby providing hair follicles with the circulation they require”
  • “re­grow your lost hair”
 
A review of our records reveals that you did not obtain marketing approval or clearance before you began offering these devices for sale, which is a violation of the law. Therefore, the iGrow Hair Rejuvenation System (iGrow) and the Revage 670 Laser System are 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 devices are 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 devices 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 devices is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html.  The FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.
 
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.
 
Your firm’s response should be sent to: Mr. Blake Bevill, Director, Compliance Branch, Food and Drug Administration, Los Angeles District Office. Refer to the Unique Identification Number CMS case # 233517 when replying.  If you have any questions about the contents of this letter, please contact: Dr. Raymond W. Brullo, Compliance Officer, at 949-608-2918.
 
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. 
 
 
Sincerely,
/S/                 
Alonza E. Cruse, Director
Los Angeles District
 
Cc:     
 
California Department of Public Health
Food and Drug Branch
PO Box 997435
1500 Capitol Avenue, MS-7602
Sacramento, CA   95899-7413
 
Morgan Pepitone, Partner
100 Bayview Circle, Suite 2200
Newport Beach, CA 92660
 
Gavin Tucker, Partner
100 Bayview Circle, Suite 2200
Newport Beach, CA 92660
 
Jeffrey Braille, Partner
100 Bayview Circle, Suite 2200
Newport Beach, CA 92660