Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
August 5, 2010
Chief Executive Officer
2600 N. Military Trail, Suite #410
Boca Raton, FL 33431
Dear Mr. Goldstein:
During an inspection of your firm located in Boca Raton, Florida on December 30, 2009 through January 8, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the BAX3000. 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.
Our inspection revealed that the BAX3000 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 device is also misbranded under section 502(0) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of your firm's 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 new 510(k) is required for the intended use of providing therapy which positively conditions the patient to react appropriately to normally harmless substances, eliminating the mediated responses that often trigger allergies, asthma, IBS, migraine, eczema, celiac disease and chronic fatigue symptoms, effectively strengthening the nervous system. A new 510(k) is needed to establish substantial equivalence to predicates, if existent for these new intended uses. Further, a new 510(k) is required to substantiate these following statements contained within the website labeling which represent or suggest that the device is adequate and effective for the treatment of the cited conditions:
- "Are you tired of suffering needlessly from red runny noses, fatigue, headaches, migraines, sinus pressure, wheezing, coughing, sneezing, indigestion, unsightly rashes such as eczema, Rosacea, and psoriasis?"
- "I did not get my usual reaction to poison ivy after this treatment."
- "Bax 3000 successful in treating pet dander allergy.[sic]"
- " ...patient who has struggled with life-long allergies - which are no longer an issue after BAX 3000 Neurological Stress Reduction Therapy."
- "Find news and press releases on NSRT [(Neurological Stress Reduction Therapy)] and how it can help normalize behavior among children with ADD, ADHD, Autism and Asperger's Syndrome."
- "Find news and press releases about substance specific stressors that trigger digestive problems including IBS and how the symptoms can be alleviated through NSRT."
All of the above claims are new and significantly different from the intended use, relaxation training of the Digital Conductance Meter device cleared as a biofeedback device in submission (b)(4).
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 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/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The BAX3000 is also misbranded under Section 502(o), 21 U.S.C. § 352(o), in that the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510, 21 U.S.C. § 360; was not included in a list required by section 510(j), 21 U.S.C. § 360(j); or a notice or other information respecting the device was not provided to the FDA as required by section 510(k), 21 U.S.C. § 360(k).
Our inspection also revealed that your firm's BAX3000 devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, your firm's failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
A follow up inspection will be required to assure that corrections are adequate.
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.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Mr. Alejo at (407)475-4731.
In addition, FDA has noted nonconformances with regard to section 501(h) of the Act [21 U.S.C. § 351(h)], due to deficiencies of the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found in 21 CFR 820. These deviations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm failed to establish complaint handling procedures to ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting.
2. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. For example, your firm failed to demonstrate that the device's instruction manual was approved prior to distribution to the end users.
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 Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance 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.
Emma R. Singleton
Director, Florida District
This page was posted on November 17, 2010.