Bradley D. Back
Back To Back Medical, LLC
403 Cutchins Mill Road
Chipley, Florida 32428
During an inspection of your firm located in Chipley, Florida on November 6 – 7, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm imports, remanufactures, and repairs a variety of reusable pulse oximetry (SpO2) probes and sensors. 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.
Additionally, under 21 CFR 807.3(d), FDA considers your firm to be a manufacturer with respect to your firm’s remanufacture of reusable SpO2 probes and sensors as your firm does not use the same component specifications as the original OEM (original equipment manufacturer). Significant changes made to the device components such as cables, photo detectors, and LEDs during your firm’s remanufacturing activities could affect the performance and/or safety specifications. Furthermore, the changes you make during remanufacturing of the reusable SpO2 devices may involve changes not covered by the premarket notifications held by the OEMs.
The current 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, its 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.
We received your written response dated November 21, 2013, concerning our investigator’s observations issued to you on the Form FDA 483, Inspectional Observations (FDA 483). In your response, you failed to outline the specific steps that you will take to establish and follow written procedures and policies designed to comply with current FDA regulations, therefore; your response is inadequate.
The violations include, but are not limited to, the following:
1. You failed to establish and maintain procedures to control the design of your SpO2 devices in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
For example, your firm failed to develop procedures for design control. Additionally, during the inspection, you stated your firm has developed drawings of different designs of SpO2devices; however, your firm has not documented whether the significant changes performed in the remanufacturing of the SpO2 devices would require the firm to submit a 510(k) submission.
2. You failed to establish procedures for corrective and preventive action (CAPA), as required by 21 CFR 820.100(a).
For example, your firm failed to establish procedures for the following requirements:
a) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems;
b) Investigating the cause of nonconformities relating to product, processes, and the quality system;
c) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
d) Verifying or validating the CAPA to ensure such action is effective and does not adversely affect the finished device;
e) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
f) Ensuring information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and,
g) Submitting relevant information on identified quality problems, as well as CAPAs, for management review.
3. You failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Such procedures shall ensure complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA per 21 CFR 803.
For example, your firm has not established standard operating procedures to determine if a complaint received represents an MDR reportable event. You failed to implement a standard operating procedure to ensure:
a) All complaints are processed in a uniform and timely manner;
b) Oral complaints are documented upon receipt; and,
c) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA, as required by 21 CFR 803.
4. You failed to establish and maintain procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
For example, you stated your firm has not established purchasing control procedures. Additionally, your firm has not performed an evaluation of your suppliers of cables, photo detectors, and LEDs used in the manufacture of your reusable SpO2 devices. Your firm has also not established and maintained a record of acceptable suppliers.
5. You failed to establish 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.
6. You failed to establish and maintain procedures for acceptance activities, including inspections, tests, or other verification activities, as required by 21 CFR 820.80(a).
For example: Your firm has not established a written acceptance procedure and has no documentation of testing on your finished SpO2 devices, to include, what acceptance activities are performed and the results; the signature and date of the individual(s) conducting the acceptance activities; where appropriate, the equipment used; and instructions for when failing results are obtained.
Additionally, as required by 21 CFR 820.80(e), you must document and maintain acceptance activities as part of the Device History Record (DHR).
7. You failed to establish, maintain, and document procedures for ensuring all personnel are trained to adequately perform their assigned responsibilities and for identifying training needs, as required by 21 CFR 820.25(b).
For example, your firm failed to document training activities for employees involved in manufacturing processes such as soldering, gluing, and silicone application to ensure that each process is completed to specifications consistently. In addition, procedures for identifying training needs were not established, documented, and implemented to ensure all personnel are trained to perform their assigned duties.
8. You failed to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a).
For example, your firm has not established procedures to ensure equipment used to test finished SpO2 probes is routinely calibrated and maintained.
9. You failed to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications. Where process controls are needed they shall include:
a) Documented instructions, standard operating procedures (SOPs), and methods that define and control the manner of production;
b) Monitoring and control of process parameters and component and device characteristics during production;
c) Compliance with specified reference standards or codes;
d) The approval of processes and process equipment; and
e) Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples.
For example, your firm has no process controls such as documented instructions, incoming and finished product inspection and testing, or manufacturing procedures to cover the processes performed at your facility.
Our inspection also revealed that your medical 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 as required by or under section 519 of the Act (21 U.S.C. § 360i) and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. The significant violation includes but is not limited to, the following:
Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, you told the investigator, during the inspection, you were not aware of this requirement and your firm does not have MDR procedures.
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 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 device have been corrected.
Please notify this office in writing within fifteen (15) business days from the date you receive 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 you have taken. If your 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 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this letter.
Your response should be sent to: Erica M. Katherine, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Erica M. Katherine at (407) 475-4731.
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 FDA 483 issued at the closeout 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 to bring your products into compliance.
Elizabeth W. Ormond
Acting Director, Florida District