Inspections, Compliance, Enforcement, and Criminal Investigations

Tiller MIND BODY, Inc. 2/25/15

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

 

February 25, 2015
 
2015-DAL-WL-09
 
WARNING LETTER
 
UPS Overnight
 
Jeri C. Tiller, President and CEO
Tiller Mind Body, Inc.
10911 West Avenue
San Antonio, Texas 78213
 
Dear Ms. Tiller:
 
During an inspection of your firm located in San Antonio, Texas on June 23, 2014 through June 26, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the LIBBE Colon Hydrotherapy Irrigation System (“LIBBE 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 any function of the body.
 
FDA has reviewed the inspection evidence, including your firm’s website, operations manual, and promotional materials, and determined that the LIBBE 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 (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g) for the device as described and marketed. The LIBBE System is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution a device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. 360(k), and Title 21, Code of Federal Regulations (CFR), 807.81(a)(3)(ii). 
 
Specifically, the LIBBE System was cleared under K941279 with the following indications: colon cleansing when medically indicated, such as before radiological or endoscopic examinations. A device classified under 21 CFR 876.5220 (colonic irrigation system) is regulated as a class II device when the device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations (21 CFR 876.5220(b)(1)). However, when a device classified under 21 CFR 876.5220 is intended for other uses, including colon cleansing routinely for general well being, it is regulated as a class III device and premarket approval is required (21 CFR 876.5220(b)(2)). Your firm’s promotion of the device provides evidence that the device is intended for general well being and other non-medically indicated uses, which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval.   Examples include claims that the LIBBE System: 
    • is a restorative procedure;
    • improves the hydration status of the client/patient…and cleanses tissues at the cellular level and removes toxins;
    • induces relaxation and contraction of colon muscular walls…and promotes the physiologic flora;
    • may be applied to a child experiencing difficult elimination;
    • may be used for resolution of the bowel telescoping upon itself, common in infants; and
    • may treat constipation due to pheochromocytoma in children.
 
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 CFR 807.81(b)]. The kind of information your firm needs to submit in order to obtain approval or clearance for your device is described on the Internet at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
 
The LIBBE System is also misbranded under section 502(a) of the Act, 21 U.S.C. 352(a), in that the labeling of the device, namely its promotional materials on your firm’s website, contains statements that are misleading in accordance with 21 CFR 807.97, because such statements create an impression of official approval of a device due to clearance of a premarket notification submission. Specifically, your firm’s website states that “[i]n the treatment of every disease, the colon must be considered. Cleansing the colon using safe FDA approved Colon Hydrotherapy Devices is the best start.” Your firm’s website also states that LIBBE System components, including colonic nozzles, are “FDA Approved.” The LIBBE System was not approved by the FDA, but was determined to be substantially equivalent within the meaning of section 513(i)(1)(A) of the Act, 21 U.S.C. 360c(i)(1)(A).
 
Additionally, your firm’s promotional materials include statements that the use of the LIBBE System: (1) promotes well-being; (2) has a restorative procedure which is both relaxing and effective; (3) improves a patients’ hydration status; facilitates peristalsis and improves an atonic bowel condition; and (4) would obviate the need for laxatives and provide a more complete colon cleansing process for barium enema examinations.  However, your firm has not submitted to FDA, and the agency is not otherwise aware of, any evidence that might support such claims. We also have significant concerns about colon cleansing being associated with (1) the use in children experiencing difficult elimination; (2) the use in the management of childhood intussusception; and (3) the use in the control of symptoms of pheochromocytoma in children. Based on a review of the gastroenterology literature, these claims may raise serious safety concerns.
 
FDA’s inspection also revealed that the LIBBE 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 (CGMP) requirements of the Quality System (QS) regulation found at 21 CFR Part 820. We received a response from your firm dated July 11, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm at the conclusion of the inspection. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
  1. Failure to maintain complaint files and 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, a review of your firm’s complaint handling procedure, “Complaint Handling & Parts Returned with Test” (QA-SOP-0017, revision 6, dated June 10, 2014, and revision 5, dated February 1, 2011), found that the following were not contained within the Standard Operating Procedures (SOPs):
 
A.   A requirement that oral complaints be documented upon receipt (see 21 CFR 820.198(a)(2)). Specifically, a complaint, received by your firm on January 11, 2013, and subsequently reported to FDA as a Medical Device Report (MDR) event on January 21, 2013, was not documented as complaint 13-005 until February 11, 2013, which was a month after initial receipt of the complaint.
 
B.   A requirement that all complaints shall be reviewed and evaluated to determine whether an investigation is necessary (see 21 CFR 820.198(b)). Specifically, section 4.1.5 of QA-SOP-0017, revision 6, only states that complaints involving death, injury (of any kind), hazard to safety, and/or failure of the device to meet its performance parameters shall be investigated. 
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm has yet to update or provide complaint filing procedures that meet the requirements of 21 CFR 820.198. Also, your firm has provided no information to demonstrate how it will ensure that employees document complaints upon receipt. Additionally, your firm has provided no evidence to demonstrate that it reviewed its files to ensure that any events submitted as MDRs have been appropriately documented as complaints.
 
2.    Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, with regards to CAPA-13-0003, which was initiated because an untrained therapist used the LIBBE Colon Irrigation System on a patient, your firm’s record for this CAPA did not include a description and documentation of the actions taken to verify the effectiveness of the corrective action. Rather, your CAPA record only stated that the corrective action was verified.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that training would be conducted at the facility where the untrained therapist used the LIBBE System. However, your firm did not provide information about actions (e.g., training, informational mailing reminder) it will take to ensure such problems do not occur in the future.
 
Our office requests that Tiller Mind Body, Inc. immediately cease activities that result in the misbranding or adulteration of the LIBBE System, such as the commercial distribution of the device for the uses discussed above.
 
A follow up inspection may be required to assure that your firm’s corrections and/or corrective actions are adequate.
 
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/or 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 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.
 
Your firm’s response should be sent to: Dallas District Office, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. We remind you that only written communication is considered official. If you have any questions about the contents of this letter, please contact: John W. Diehl at 214-253-5288.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of your firm’s violations.  It is your firm’s responsibility to ensure compliance with all 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/                                                                              
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
 
CC:
Tom Brinck, Manager
Drugs and Medical Devices Group
Texas Department of State Health Services
8407 Wall Street, S-124

Austin, Texas 78714

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