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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Capillus LLC 9/20/13

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
 
Telephone: 407-475-4700
FAX: 407-475-4770 

 

VIA UPS
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-13-29
September 20, 2013
 

 


Mr. Carlos Pina
Owner
Capillus, LLC
9818 SW 111 Terrace
Miami, FL 33176
 
Dear Mr. Pina:
 
During an inspection of your firm located in Miami, from Florida on April 26 – May 16, 2013, investigators from the United States Food and Drug Administration (FDA) determined that your firm is importer and manufacturer of the Capillus272 laser therapy system. 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 is intended to affect the structure or 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 the Capillus272 laser therapy 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 written responses from (b)(6), Counsel to Capillus, LLC dated May 16, 2013 and June 12, 2013, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to your firm.  Your response stated your firm plans to remove medical device claims until such time as the firm is prepared to market its product as a medical device. Your response also states you plan to implement quality system regulations and become compliant with Electronic Product Radiation Controls. Your response did not include a corrective action plan, timeframe for the completion of corrections, and as of the writing of this letter your firm’s websites have not changed to remove medical device claims. Accordingly, your firm’s responses, in relation to each of the noted violations, are not adequate.
 
The violations include, but are not limited to, the following:
 
  1. Failure to establish and maintain procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, you stated your firm has not established purchasing control procedures, specifications for purchased products, or agreements with suppliers to notify you of changes in products or services.  Additionally, your firm has not performed an evaluation of your suppliers of the Capillus272 device and associate accessories including the battery pack and battery charger.
  2. 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, there are no written complaint procedures.
  3. Failure to establish and maintain corrective and preventive action procedures, as required by 21 CFR 820.100(a). For example, there are no written Corrective and Preventive Action procedures.
  4. Failure to identify through suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria, as required by 21 CFR 820.86. For example, there no records maintained to indicate the acceptance status of product to designate the conformance or nonconformance of product throughout manufacturing steps performed at your firm. 
  5.  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 failed device accessory or component for your Capillus272 device and does not conduct an investigation of device failures.  Your firm did not document that such investigations were not necessary. Examples of these complaints include the following:
 
i.    Complaint 00001003 – opened 02/05/13 for “two bad battery packs” and status was closed on 03/07/13, with the resolution as “send 2 (Old) battery packs”;
 
ii.    Complaint 00001004 – opened on 02/06/13 for “Broken Battery Clip” and status remains open as of 04/29/13, with resolution “Send S. M. Battery Packs”;
 
iii.    Complaint 00001005 – opened on 03/07/13 for “The battery charger of the laser hat doesn’t work anymore” and closed on 03/07/13 with resolution “Exchange battery pack” as the battery pack and not the charger was the problem; and
 
iv.    Complaint 000010006 – opened on 03/28/13 for “Problem was Battery Pack” and status was closed on 04/29/13, with resolution “Replace with New Unit”.
 
  1. Failure to establish procedures to control labeling activities, as required by 21 CFR 820.120. During our inspection you verbally acknowledged the following:
 
a)    Your firm has not established procedures for the control of labeling activities, including but not limited to the specification for printing and placement of labels on device packaging;
 
b)    Your firm does not perform label approval and reconciliation;
 
c)    Your firm does not document labeling activities in a DHR; and
 
d)    Your firm’s Instructions for Use, brochures and other labeling  for the Capillus272 are not revision controlled documents.
 
  1. Failure to establish and maintain adequate procedures to ensure that Device History Records (DHRs) for each batch or lot are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR) as required by 21 CFR 820.184. Specifically, your firm has no Device History Records (DHR) for Capillus272 laser hair therapy device that you label and repackage and you do not store a copy of the label utilized on the device in a DHR. In addition, you have not established procedures for device history records for the devices you label and repackage.
  2. Failure to establish a device master record, including or referring to the location of your device specifications, production process, quality assurance, and packaging/labeling for the Capillus272 hair laser therapy device you import and distribute, as required by 21 CFR 820.181.  For example, your firm has no Device Master Record which includes or refers to the location of:
 
a)    Device specifications including appropriate component specifications;
 
b)    Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; and
 
c)    Packaging and labeling specifications, including methods and processes used.
 
 
Our inspection also revealed that your firm's Capillus272 laser therapy system is 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 requiredby or under Section 519 ofthe Act, (21 U.S.C. § 360i), and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
 
Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm has no written MDR procedures.
 
In addition, our inspection revealed that your firm has been marketing the Capillus 272 laser therapy system in the United States. A review of our records indicates that your firm did not obtain marketing approval or clearance before you began offering this device for sale, which is a violation of the law. Therefore, the Capillus272 laser therapy system 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 to being a "device," the Capillus272 is an "electronic product" subject to compliance with Subchapter C of the Act, Electronic Product Radiation Control, the requirements at 21 CFR 1000-1005, and the performance standards at 21 CFR 1010, 1040.10, and 1040.11. Your firm failed to comply with the regulations regarding product safety, reports, and record keeping.
 
1.    Failure to submit a Product Report prior to introduction into commerce, as required by 21 CFR 1002.10.   For example, CDRH has not received a laser Product report from either your firm, Capillus, or from the (b)(4), on the Capillus272 laser product demonstrating compliance to the laser product performance standard, 21 CFR 1040.10 and 11.
 
Your firm’s response is adequate because CDRH received the laser product report, Accession number 1310455, dated May, 31, 2013.
 
2.    Failure to certify the laser products that they comply with the laser product performance standard, as required by 21 CFR 1010.2.  For example, shipped units were not tested following an adequate quality testing program and did not carry the certification label. Furthermore, the Capillus272 laser hair therapy unit is not certified by the (b)(4)
 
Your firm’s response is adequate because the laser product report, Accession number 1310455, dated May, 31, 2013, states that your firm now certifies and attaches a certification label, pursuant to 21 CFR 1010.2.
 
3.    Failure to identify the manufacturer of record in a label on the product, as required by 21 CFR 1010.3.  For example, neither the Chinese manufacturer nor your firm attaches a manufacturer identification label to each unit.
 
Your firm’s response is adequate because the laser product report, Accession number 1310455, dated May, 31, 2013, states that your firm now attaches a manufacturer identification label, pursuant to 21 CFR 1010.3.
 
4.    Failure to affix a warning logotype label to each unit, as required by 21 CFR 1040.10(g)(2).  For example, the units do not carry the required Class IIIa warning logotype label.
 
Your firm’s response is adequate because the laser product report, Accession number 1310455, dated May, 31, 2013, includes a new Operating and Care Instructions manual with additional safety labeling for Class IIIb and appears to comply with 21 CFR 1040.10(g)(3).
 
5.    Failure to provide reproductions of all required safety labels in the user information, as required by 21 CFR 1040.10(h)(1)(iii).  For example, the Operating and Care instruction pamphlet lacks the required warning logotype and aperture labels.
 
Your firm’s response is adequate because the laser product report includes a new Operating and Care Instructions manual with additional safety labeling and appears to comply with 21 CFR 1040.10(h)(1).
 
6.    Failure to establish records of test results for electronic product radiation safety, as required by 21 CFR 1002.30(a)(2). For example, your firm did not have on hand test results for electronic product radiation safety, including the control of unnecessary, secondary, or leakage electronic product radiation. Specifically, your firm fails to maintain any finished product test records, upon which to base certification. Additionally, your firm’s Marketing Director stated that your firm does not receive a certification from the manufacturer regarding the laser’s compliance.
 
The responses dated May 21, 2013 and June 12, 2013, submitted by legal counsel (b)(6), are not adequate. We evaluated your firm’s laser Product Report and our findings are indicated below, following the list of observations.
 
7.    Failure to establish records containing a description of quality control procedures with respect to electronic product radiation safety, as required by 21 CFR 1002.30(a)(1).  For example, your firm did not have any established quality control procedures regarding radiation safety for the Capillus272 laser product.
 
The responses dated May 21, 2013 and June 12, 2013, submitted by legal counsel (b)(6), are not adequate. We evaluated your firm’s laser Product Report and our findings are indicated below, following the list of observations.
 
8.    Failure to display the appropriate warning logotype label on sales brochures, as required by 21 CFR 1040.10(h)(2)(i). For example, sales brochures and the Capillus website lack the required label.
 
The responses dated May 21, 2013 and June 12, 2013, submitted by legal counsel (b)(6), are not adequate. We evaluated your firm’s laser Product Report and our findings are indicated below, following the list of observations.
 
The FDA’s Center for Devices and Radiological Health (CDRH) received your firm’s laser Product report, Accession number 1310455, dated May, 31, 2013, on the Capillus272 laser hair therapy system. During the review of the report, it was determined that your firm now certifies and attaches both certification and manufacturer identification labels, pursuant to 21 CFR 1010.2 and 1010.3. Furthermore, your report includes a new Operating and Care Instructions manual with additional safety labeling and appears to comply with 21 CFR 1040.10(h)(1). However, your firm’s determination that the Capillus272 laser therapy system is now a Class 3B laser product introduces the following additional noncompliances with the laser standard and the IEC 60825-1 laser standard and IEC 60601-2-22 medical laser standard, as follows:
 
  • 21 CFR 1010.2(c) Quality Assurance Procedures. Failure to provide adequate quality assurance and test procedures to demonstrate that the units are manufactured following good manufacturing practices, upon which the firm can base its certification, as required by 21 CFR 1010.2(c). For example, the product report provided inadequate quality assurance procedures and specifications as Appendix 8.1.
  • 21 CFR 1040.11(a)(1) Means of Measurement. Failure to provide a means of measurement of the radiation dose being delivered to the patient, as required by 21 CFR 1040.11(a)(1). For example, the Capillus272 model does not have any internal detection system.
  • 21 CFR 1040.11(a)(1) Internal Monitoring. Failure to provide a means of monitoring the output levels to maintain delivered levels to within +/- 20, as required by 21 CFR 1040.11(a)(1). For example, the Capillus272 model does not have any internal detection system and software to detect output level drifts and alert the user.
  • 21 CFR 1040.10(f)(5)(i) Emission Indicator. Failure to provide an emission indicator, as required by 21 CFR 1040.10(f)(5)(i). For example, the Capillus272 model does not have a dedicated emission indicator. Although laser products Class IIIa and below may utilize the actual visible beam in lieu of incorporating an emission indicator, higher Class products must comply with the requirement or request approval of a variance, following 21 CFR 1010.4.
  • 21 CFR 1040.10(f)(5)(ii) Emission Delay. Failure to provide an emission delay, as required by 21 CFR 1040.10(f)(5)(ii). For example, the Capillus272 model does not have an emission indicator with delay circuitry to permit users to avoid hazardous Class IIIb/3B levels of laser radiation prior to emission.
  • 21 CFR 1040.10(f)(6)(i) Beam Attenuator. Failure to provide a beam attenuator, as required by 21 CFR 1040.10(f)(6)(i). For example, the Capillus272 model does not have a beam attenuator. Although laser products Class IIIa and below may utilize an on/off type power switch in lieu of incorporating a beam attenuator, higher Class products must comply with the requirement or request approval of alternate means, pursuant to 21 CFR 1040.10(f)(6)(ii).
  • 21 CFR 1040.10(h)(1)(i) Remote Interlock Connector. Failure to include adequate instructions for use of the remote interlock connector, required for Class IIIb/3B laser products, in user instructions, as required by 21 CFR 1040.10(h)(1)(i). For example, the user manual provided by the firm contains no reference or instructions for utilizing the required remote interlock connector.
  • 21 CFR 1040.10(h)(1)(i) Key Control. Failure to include adequate instructions for use of the key control, required for Class IIIb/3B laser products, in user instructions, as required by 21 CFR 1040.10(h)(1)(i). For example, the user manual provided by the firm contains no reference or instructions for utilizing the required key control.
  • 21 CFR 1040.11(a)(2) Calibration Procedures. Failure to include adequate calibration instructions and a schedule for the purchaser, required for Class IIIb/3B medical laser products, in user instructions, as required by 21 CFR 1040.11(a)(2). For example, the user manual provided by the firm contains no calibration instructions.
 
These violations are prohibited acts under section 538(a)(4) of the Act, 21 U.S.C. § 360oo(a)(4), which prohibits any manufacturer from failing or refusing to submit reports required pursuant to section 537(b) of the Act. Violations of section 538 are grounds for enforcement action under section 539 of the Act. 
 
Copies of the Federal Performance Standards, compliance guides, radiation safety product report guides, and other documents related to laser products are available on FDA's web site at: http://www.fda.gov/RadiationEmittingProducts/RadiationEmittingProductsandProceures/HomeBusinessandEntertainment/LaserProductsandlnstruments/default.htm.
 
This letter also confirms notifications by phone and email on June 21, 2013, to you and (b)(6), Counsel to your firm. In these notifications we requested that you immediately correct the following non-compliance with the performance standard:
 
During the inspection you provided a retail unit of your Capillus272 laser hair therapy system to be tested by FDA laboratories. The device provided was Capillus272 Model: HPro-1 Serial #: SFM-HProl-13-0372. Our laboratory tested this unit and found the device exceeded the IEC 60825 Class 3R limit of 5 mW. Confirmation test measurements ranged from (b)(4) on 9 laser diodes, and (b)(4) from the rim.
 
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 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.
 
You 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 Food and Drug Administration without further notice.  These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.  Also, 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 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 device have been corrected.
 
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions you have taken.  If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities.  If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this letter.  
 
Your response should be sent to: Erica M. Katherine, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Erica M. Katherine at (407) 475-4731.
 
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 Form FDA 483, Inspectional Observations (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management 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. 
 
Sincerely,
/S/
Emma R. Singleton
Director, Florida District