- Medical Devices
Recipient NameMichael Whitehurst
- Mibo Medical Group
2526 Manana Road, Suite 105
Dallas, TX 75220
- Issuing Office:
- San Francisco District Office
CMS # 558900
UNITED PARCEL SERVICE
November 20, 2018
Michael Whitehurst, CEO
MiBo Medical Group
2526 Manana Road, Suite 105
Dallas, Texas 75220
Dear Mr. Whitehurst:
During an inspection of your firm located in Dallas, Texas, on May 7, 2018 through May 10, 2018, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures MiBo Thermoflo. 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 to affect the structure or any function of the body.
This inspection revealed 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received your firm’s FDA 483 responses, dated May 15, 2018 and October 9, 2018. We have reviewed your firm’s responses and acknowledge your firm has committed to developing procedures; however, to date your firm has not provided objective evidence of corrections made, and therefore we cannot evaluate the adequacy of your responses at this time.
1. Failure to establish procedures for design control, as required by 21 CFR 820.30. Specifically, your firm has not established and maintained procedures to control the design of your Class II MiBo Thermoflo device to ensure specified design requirements are met. For example,
a. Procedures for design inputs have not been established, as required by 21 CFR 820.30(c). You provided a document entitled “First mock up prototypes,” hand-dated “12/12/12,” which includes rough sketches of the device and handwritten notes. This document does not describe or reference design or development activities or define responsibility for implementation. You also provided a document entitled “Reports + Studies,” which appears to be a chain of emails from 2014 in which you emailed to an unidentified recipient several abstracts by different authors studying the effects of (b)(4) on eyelids. Neither of the documents include procedures to ensure the design requirements are appropriate and address intended use of the device, including the needs of the user and patient.
b. Procedures for design outputs have not been established, as required by 21 CFR 820.30(d), including procedures containing acceptance criteria and those design outputs essential for the proper functioning of the device.
c. Procedures for design verification have not been established, as required 21 CFR 820.30(f). During the inspection, your firm provided “Clinical Temperature Data for the MiBo Thermoflo” document, dated August 31, 2017, a document that appears to be a clinical assessment of the MiBo Thermoflo device. This study purportedly demonstrates the temperature of the device provides therapeutic levels of heat to a patient’s eyelids without exposing the patient to non-therapeutic temperatures, citing a temperature range on the external lid surface of (b)(4)° - (b)(4)°F. This study also states the device has an absolute maximum temperature of (b)(4)°F “when safeguards…fail.” You also provided “Usability Engineering File,” revision 1C, dated March 6, 2018, which indicates the temperature of the device on the patient would max out at “(b)(4) air/(b)(4) skin.” In contrast, your MiBo Thermoflo User Manual states the “system will control the temperature to 108°F,” and your “Final Inspection Report,” revision 1.2H, dated February 2, 2017, indicates in the revision history that your firm updated the device to “default high temperature to (b)(4)F” on October 7, 2016. You were unable to provide evidence you have verified the design output meets the design inputs requirements, including the maximum temperature to which the device defaults.
d. Procedures for design validation have not been established, as required by 21 CFR 820.30(g). You provided a document titled “(b)(4) Studies” with no effective date, study date, or revision number, that appears to be a design validation. In reviewing this document, it is unclear if the validation was performed on initial production units, and the document does not contain defined operating condition, such as whether ultrasound gel was used on test subjects, as required by your user manual, or the number of treatments per test subject. Your “Usability Engineering File” indicates patients should be treated (b)(4) for (b)(4), while your MiBo Thermoflo product brochure recommends three treatments, two weeks apart. This design validation also fails to include software validation to assure software will perform as intended and will not prevent safe operation by the user.
e. Risk analysis was not performed per your “Risk Management Plan,” document B9001500001, revision B. Per your procedure, risk management plan shall be done initially as part of the design, and risk management will continue throughout the life cycle of the product. To date, you have not conducted risk analyses to identify possible hazards associated with the design of your device in both normal and fault conditions.
f. Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.30(j). Specifically, your firm has not established a DHF for your MiBo Thermoflo device, demonstrating the design was developed following the requirements of 820.30. No records were provided demonstrating your firm 1) established a design plan, completed design inputs, and design outputs; 2) conducted design verification, risk analysis, or design reviews; and 3) correctly translated the design into product specifications.
Sufficient evidence was not provided during the inspection demonstrating your firm has met the regulation for design controls for the initial design, design inputs and design outputs, design transfer, design verification and/or validation, or any subsequent design changes, including changes in software, for the MiBo Thermoflo device you have been distributing since 2014.
2. Failure to establish procedures for corrective and preventive actions, as required by 21 CFR 820.100. Specifically, you stated during the inspection you were unaware of the requirements for corrective and preventive action (CAPA) procedures and you did not have CAPA procedures. Your firm is required to establish CAPA procedures to include at least the following requirements:
a. Analyzing sources of quality data to identify existing and potential causes of nonconforming product, as required by 21 CFR 820.100(a)(1);
b. Investigating causes of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100(a)(2);
c. Identifying actions needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3);
d. Verifying or validating the corrective and preventive action to ensure such action is effective and does not adversely affect the device, as required by 21 CFR 820.100(a)(4); and,
e. Implementing changes needed to correct and prevent identified quality problems, as required by 21 CFR 820.100(a)(5).
3. Failure to establish procedures to ensure all purchases or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. You stated during the current inspection that MiBo Medical is responsible for purchasing components of the MiBo Thermoflo device, which are then distributed to your contract manufacturer for assembly into the finished device, yet you have not established procedures governing the evaluation of these suppliers, contractors, and consultants on their abilities to meet specified requirements.
During the inspection, you provided a “List of Approved Vendors” and “List of Critical Components,” neither of which contain documented effective dates or evidence of review and approval. In comparing these two records, we noted two of your critical components are being supplied by non-approved suppliers.
a. Your “List of Critical Components” lists (b)(4) as the manufacturer/supplier of part number 3931090, for the AC power cord; however, (b)(4) is not listed on your “List of Approved Vendors,” nor is this part number.
b. Per your “List of Critical Components,” the supplier of the “rear panel (b)(4),” part number 3931021, is (b)(4); however, per your “List of Approved Vendors,” only (b)(4) is approved to supply part number 3931021.
Once your firm has established the required procedures and evaluated your suppliers based on their ability to meet your specified requirements, you must define the type and extent of control applied based on the results of your evaluation, as required by 21 CFR 820.50(a)(2).
4. Failure to establish procedures for finished device acceptance, as required by 21 CFR 820.80(d). During the inspection, you described your device release process, which includes temperature testing (b)(4) prior to releasing to your customer. Temperature testing of your device was described as comparing the temperature of the “(b)(4)” to a (b)(4) to ensure the temperature reached by the eye piece matches your contract manufacturer’s final inspection temperature. For example, you provided a copy of the “Final Inspection & Testing” record dated February 6, 2018 for serial number (b)(4); per this record, the contract manufacturer’s final inspection temperature was (b)(4)°F. Your handwritten note on this record for your own final inspection temperature is (b)(4)°F, which is higher than both your contract manufacturer’s documented temperature and the maximum temperature your user manual states the device will reach (108°F). You have not established procedures for finished device acceptance, or protocols or acceptance criteria, to ensure your device meets acceptance criteria, nor have you validated this test method for its intended use.
5. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). During our recent inspection, your firm did not have a procedure governing complaint handling; yet you stated during the inspection you recently received a complaint about a patient experiencing swollen eyes after receiving treatment, but that the patient’s issue was not device related. However, no complaint record was created, and there was no documentation that you evaluated this complaint to determine whether an investigation was necessary. During the inspection, you stated you were responsible for all customer complaints; however, since you began distributing the MiBo Thermoflo device in 2014, you have not established complaint handling procedures or documented any complaints.
6. Failure to develop, maintain, and implement written medical device reporting (MDR) procedures, as required by 21 CFR 803.17. Specifically, your firm has not developed any MDR procedures.
7. Failure to establish a device master record, as required by 21 CFR 820.181. Specifically, you firm failed to establish and maintain a device master record (DMR) for the MiBo Thermoflo device that includes or refers to the location of all device, quality, production and process, packaging, and labeling. You have been distributing this device since 2014.
8. Failure to establish and maintain procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. Your firm began manufacturing and distributing the MiBo Thermoflo device in 2014, yet your firm has not conducted any internal audits.
9. Failure of management with executive responsibility to establish its policy and objectives for, and commitment to, quality, as required by 21 CFR 820.20. Specifically, no quality policy was available for review during the inspection, including your firm’s organizational structure, as required by 21 CFR 820.20(b), to ensure devices are designed and produced in accordance with the quality system regulations. No evidence was provided during the inspection that management with executive responsibility have reviewed the quality system to ensure the quality system meets the requirements of the regulation.
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 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 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 electronically to US FDA, Office of Medical Devices and Radiological Health Operations Division 3/West, at ORADevices3FirmResponse@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact Compliance Officer Jamie M. Bumpas at 214-253-5336, or at Jamie.email@example.com.
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.
Shari J. Shambaugh
Program Division Director
Medical Device & Radiological Health Operations West/Division 3
Glinda Whitehurst, CFO
MiBo Medical Group
2526 Manana Road, Suite 105
Dallas, Texas 75220