| Public Health Service Food and Drug Administration |
| Denver District Office Bldg. 20-Denver Federal Center P.O. Box 25087 6th Avenue & Kipling Street Denver, Colorado 80225-0087 Telephone: 303-236-3000 FAX: 303-236-3551 |
Department of Health and Human Services
August 25, 2011
WARNING LETTER
VIA UPS
Mr. Joseph S. Galloway
President and CEO
Galloway Technologies, LLC
3736 Panarama Dr.
Saratoga Springs, UT 84045
Ref: DEN-11-18-WL
CMS Case #175552
Dear Mr. Galloway:
During an inspection of your firm located in Saratoga Springs, UT on February 28 through March 2, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Asyra Galvanic Skin Response Measurement devices. 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 these devices are 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, their 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 Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive actions and failure to document the results and activities, as required by 21 CFR 820.100 (a) and (b). For example, during your firm’s inspection, you acknowledged that corrective and preventive actions procedures and records have not been established.
2. 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, during your firm’s inspection, you acknowledged that complaint handling procedures and records have not been established.
3. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, during your firm’s inspection, you acknowledged that procedures and records for controlling nonconforming products have not been established.
4. Failure to maintain adequate Device Master Records (DMRs) and to ensure that each DMR is prepared and approved in accordance with part 820.40, as required by 21 CFR 820.181. For example:
a. Your firm’s assembly records include device specification records, drawings and compositions for some of your device components. However, formal Device Master Records (DMRs) have not been prepared and approved in accordance with 21 CFR 820.40.
b. Although some assembly instructions were provided, you could not provide records to demonstrate that a complete Device Master Record (DMR) had been established.
5. 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(a). For example, During your firm’s inspection, you acknowledged that design control procedures have not been established, including the following design control elements:
a. A Design History File for the Asyra Galvanic Skin Response measurement device was not established.
b. A design plan, design input requirements, and design output were not established.
c. Formal design reviews were not conducted or documented.
d. Design verification and validation activities were not conducted or documented. For example, there are no records to demonstrate that the Asyra Galvanic Skin Response Measurement Device software or firmware, Version 3.1.0.7 had been validated. Additionally, there was no documentation available to demonstrate that a risk analysis was conducted.
e. Design change control procedures have not been established. Additionally, design changes have not been documented. For example, the change from using a serial port to using a USB port on the printed circuit board for connecting the Asyra Galvanic Skin Response measurement device to a computer has not been documented.
6. Failure to develop, conduct, control, and monitor production processes to ensure that the device conforms to its specifications, as required by 21 CFR 820.70(a). For example, there are no process control procedures that describe any necessary controls to ensure the Asyra Galvanic Skin Response measurement device conforms to specifications.
During your firm’s inspection, you acknowledged that the procedure and specifications have not been established.
7. Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a). For example:
a. Procedures for acceptance of incoming raw materials have not been established. There are no records to demonstrate that incoming inspection was performed on components used in the manufacture of Asyra Galvanic Skin Response measurement device between 3/01/2009 and 3/02/2011, in order to verify the components meet specified requirements.
b. Procedures are not established for finished device acceptance for the Asyra Galvanic Skin Response measurement device. Also, acceptance criteria have not been established to evaluate the Asyra device prior to release for distribution. There are no acceptance records for the approximately (b)(4) Asyra devices that were distributed between 03/01/2009 and 03/02/20111.
During your firm’s inspection, you acknowledged that these records and procedures have not been established.
8. 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, components such as battery straps, cases, printed circuit boards, and electrodes are manufactured by suppliers and the following information was not available:
a. Your firm has not documented the evaluation and approval of suppliers of components used in the manufacture or assembly of the Asyra Galvanic Skin Response measurement device.
b. Your firm has not established the requirements that must be met by suppliers and contractors.
c. Your firm does not maintain an approved suppliers list.
d. Your firm does not have a documented agreement with any component suppliers or contractors to notify it of changes made in the components supplied or services rendered.
During your firm’s inspection, you acknowledged that these procedures and records have not been established.
9. Failure to establish and maintain adequate procedures to ensure that Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR), as required by 21 CFR 820.184. For example, your firm began manufacturing and distributing in 2003. However, your firm could not provide any records showing how many devices have been manufactured or distributed.
During your firm’s inspection, you acknowledged that these procedures have not been established and could not provide the necessary records maintained in a Device History Record.
10. Failure to establish and maintain procedures to control all documents that are required by 21 CFR 820.40. During your firm’s inspection, you acknowledged that procedures to control all documents and records have not been established.
11. Failure to establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements, as required by 21 CFR 820.200(a). For example, your firm has performed servicing including replacing the speaker, fixing the connection between the wire and brass electrode, and replacing the printed circuit board when the user had broken the power adapter component of the board. However, this service was not documented, and instructions or procedures for servicing have not been established.
During your firm’s inspection, you acknowledged that procedures for performing servicing and the records documenting these reports of servicing have not been established.
12. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example: you could not provide any records to document personnel training, and acknowledged that these procedures have not been established.
13. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part, as required by 21 CFR 820.20(c). For example, during your firm’s inspection, you acknowledged that these procedures and records have not been established.
Our inspection also revealed that the Asyra Galvanic Skin Response measurement devices are 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 CFR Part 803 - Medical Device Reporting (MDR) regulation.
Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. During your firm’s inspection, you acknowledged that Medical Device Reporting procedures have not been established.
Our inspection also revealed that the Asyra Galvanic Skin Response measurement device is adulterated under 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(o) of 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)], in that a notice or other information respecting the new intended use of the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3)(ii). Specifically, the Asyra Galvanic Skin Response measurement device was cleared via K023355 for the measurement of galvanic skin response. Our inspection revealed that you are promoting the device as a system for bioenergetics medicine, as follows:
1. “The Asyra system is one of the most powerful and reasonably priced systems available to health care practitioners interested in bioenergetics medicine.”
2. “The Asyra software interface allows you to evaluate your patient’s parameters of health using information gathered through the hardware system via painless, non-intrusive handheld electrodes.”
A new 510(k) is required for these claims as they represent changes in the indications for use of the device. 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/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product 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 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 devices have been corrected.
Please notify this office in writing within fifteen business days from the date your firm receives 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 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 these 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: Food and Drug Administration, Denver District, P. O. Box 25087, (6th Avenue and Kipling Street, Denver Federal Center, Building 20) Denver, CO 80225-0087; Attention: William H. Sherer, Compliance Officer. Refer to CMS Case #175552 when replying. If you have any questions about the content of this letter, please contact Mr. Sherer at telephone number (303) 236-3051 or fax (303) 236-3551.
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 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, 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 management systems. Your firm should investigate and determine the causes of the violations, and take prompt action to correct the violations and to bring your products into compliance.
Sincerely yours,
/S/
Mark R. Madson
Acting District Director
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