Life Force of Tampa, LLC 5/21/14
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Florida District |
555 Winderley Place, Suite 200
Maitland, Florida 32751
w/ DELIVERY CONFIRMATION
May 21, 2014
Douglas G. Cornell, President
Jeffrey L. Greenacre, Secretary/Treasurer
Life Force of Tampa, LLC
4125 Gunn Highway, Suite B1
Tampa, Florida 33618-8788
Dear Mr. Cornell and Mr. Greenacre:
During an inspection of your firm located in Tampa, Florida on January 27, 2014, through January 28, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the LIFE FORCE™chamber. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a medical 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.
This inspection revealed that this device 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 regulation found at Title 21, Code of Federal Regulations (C.F.R.), 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 C.F.R. § 820.30(a)(1). For example, you have no written design control procedures to control the design of the LIFE FORCE™chamber including not having documentation of requirements for the labeling of the products.
2. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 C.F.R. § 820.100(a). For example, you do not have a written corrective and preventive action procedure.
3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and failure to maintain complaint files, as required by 21 C.F.R. § 820.198(a). For example, you do not have a written complaint procedure nor do you maintain complaint files for the complaints, you stated to the FDA investigator, your firm has received concerning the LIFE FORCE™chamber.
4. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 C.F.R. § 820.70(a). For example, the procedures you provided to the investigator, Patent Record US 8,337,385 B1, lacked adequate instructions on the methods that define and control the manner of production. Specifically, the procedures lacked adequate controls and were not monitored. The procedures outline the conduct of the manufacturing process of the LIFE FORCE™chamber, but do not include any technical or dimensional specifications that the device is to conform to.
5. Failure to establish and maintain procedures for acceptance activities, as required by 21 C.F.R. § 820.80(a). For example:
a. You have no written procedures for the final inspection of the finished device, the LIFE FORCE™chamber.
b. You have no written procedures for the incoming inspection of the sound amplifier, telescoping arms, and D.C. power converter, components of the LIFE FORCE™chamber.
We received a response from Mr. Cornell dated February 11, 2014, 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 response and concluded that it is not adequate because it did not provide any specific plan or evidence of any corrections, corrective actions, and systemic corrective actions to address the observations in the FDA 483.
This inspection also revealed that your device 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 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, the following:
Failure to develop, maintain and implement written MDR procedures, as required by 21 C.F.R. § 803.17. For example, during the January 27, 2014 through January 28, 2014, inspection of Life Force of Tampa, you stated to the FDA investigator that your firm lacks written MDR procedures.
We reviewed your firm’s response and conclude that it is not adequate. The response did not provide any specific plan or evidence of any corrections, corrective actions, and systemic corrective actions to address this observation.
A review of our records reveals that your firm has not received premarket clearance or approval to market this device in the United States, which is a violation of the law.
Therefore, the LIFE FORCEÔ
chamber is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do 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(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your 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) 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 you need 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.
Additionally, a review of our records revealed the LIFE FORCE™ chamber is also misbranded under section 502(o) of the Act, 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 of the Act, 21 U.S.C. § 360, and was not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).
We reviewed your firm’s response and conclude that it is not adequate. You state that Life Force will make no claim, either expressed or implied, that the machine is intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease, or intended. You have not informed us of any specific plan or provided information for immediate corrections and systemic corrective actions to handle the deficiencies noted during the FDA inspection.
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 deviations 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 (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 violation(s), or similar violation(s), 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 those activities. If corrections and / or corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which these activities will be completed.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Salvatore N. Randazzo, Compliance Officer, at the address noted in the letterhead. Refer to the Unique Identification Number CMS #422240 when replying. If you have questions, please contact Mr. Randazzo at (407) 475-4712 or write him at the noted address.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) 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 close-out 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 bring your products into compliance.
Elizabeth W. Ormond
Acting Director, Florida District