- Better Health Systems, Inc
- Issuing Office:
- Denver District Office
| || |
Department of Health and Human Services
|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
April 7, 2015
Richard D. Betts
Better Health Systems, Inc.
845 Winding Hills Road
Monument, CO 80132
Dear Mr. Betts:
During an inspection of your firm located in Monument, CO on December 10, 2014 through December 12, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is the specification developer and packager of Bio-Soft Oraliner (Self-Cure and Heat-Cure). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are medical 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 to affect the structure or any 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 requirements of the Quality System 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 procedures for receiving, reviewing and evaluating complaints as required by 21 CFR 820.198(a). Specifically, no procedures are in place to process, document, and evaluate complaints, or to determine if complaints represent a Medical Device Report (MDR).
2. Failure to develop and implement medical device reporting (MDR) procedures, as required by 21 CFR 803.17, including procedures for requirements such as:
a. Timely and effective identification, communication and evaluation of events that may be subject to MDR requirements.
b. Standardized review process for determining when an event meets reporting criteria.
c. Timely transmission of such reports to the FDA.
d. Documentation and recordkeeping procedures to include evaluations made, reports filed, and/or annual reports.
3. Failure to establish procedures that describe any process controls necessary to ensure conformance to specifications as required in 21 CFR 820.70(a). Specifically, your firm was not able to provide any instructions, standard operating procedures, or other methods designed to define and control the packaging and labeling of the Bio-Soft Oraliner device.
4. Failure to establish procedures to ensure that device history records for each lot of Bio-Soft devices are maintained in order to demonstrate the device is manufactured in accordance with the device master record as required in 21 CFR 820.184.
5. Failure to establish procedures to ensure all purchased or otherwise received product conforms to specified requirements as required in 21 CFR 820.50. This requirement includes evaluating your suppliers and establishing quality requirements for each incoming component, as well as defining the type and extent of control to be exercised over the product, services, suppliers, etc., based on the evaluation results.
6. Failure to establish procedures for acceptance or rejection of incoming products, and failure to maintain documentation of acceptance or rejection of incoming materials, as required by 21 CFR 820.80(b). For example, your firm receives (b)(4) and (b)(4) approximately (b)(4) from your supplier. 21 CFR 820.80(b) requires incoming product to be inspected, tested, or otherwise verified as conforming to specified requirements; however, your firm had no documentation of any inspections, tests, or other verification to demonstrate that all component shipments met their specified requirements. Although you informed the investigator that you had rejected a shipment of incoming (b)(4) in the past, you do not have documentation regarding this incident.
7. Failure to establish procedures for controlling product that does not conform to specified requirements as required by 21 CFR 820.90(a). These procedures should address the identification, documentation, evaluation, segregation and disposition of nonconforming product, as well as documenting the need for an investigation and any notification to the organization responsible for the nonconformance.
8. You have not established procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100, and including procedures for requirements such as:
a. the identification of sources of quality issues to ensure that all potential quality issues are identified;
b. the analysis of sources of quality data to identify existing or potential quality issues;
c. the investigation of the cause of nonconformities related to product, processes, and the quality system; and,
d. the verification or validation of corrective and preventive actions to ensure the actions are effective and do not adversely affect the finished device.
9. Failure to establish a procedure for quality audits, and to conduct and document quality audits, as required by 21 CFR 820.22. You do not conduct quality audits to assure the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.
To date, we have not received a written response to the form FDA-483, Inspection Observations, issued at the close of the inspection.
Our inspection also revealed that the Bio-Soft Oraliner (Self-Cure and Heat-Cure) 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 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) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices 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
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2015.
Therefore, all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
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 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 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 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 (which must address systemic problems) 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: U.S. Food and Drug Administration, Denver District Office, Building 20 – Denver Federal Center, P.O. Box 25087, Denver, CO 80225-0087, Attn: Sarah A. Della Fave, Compliance Officer. If you have any questions about the contents of this letter, please contact: Ms. Della Fave at 303.236.3006.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s 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, 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.
LaTonya M. Mitchell