Inspections, Compliance, Enforcement, and Criminal Investigations
Innovations for Access, Inc., dba HemoBand Inc. 10-Mar-08
Department of Health and Human Services
Public Health Service
March 10, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-11
Dr. Gregory L. Geary, President
Innovations for Access, Inc., dba HemoBand Inc.
515 Saltzman Road, #797
Portland, Oregon 97229
Dear Dr. Geary:
During an inspection of your firm located at 1815 NW 169th Place, Suite 6030, Beaverton, Oregon, on September 25, 2007, and October 5, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the HemoBand in two forms, sterilized (HemoBand-1M) and unsterilized (HemoBand-NS). 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.
Our inspection and a review of our records revealed that you have not obtained marketing approval or clearance before you began offering the unsterilized HemoBand-NS for sale, which is a violation of the law. Specifically, the unsterilized HemoBand-NS 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). Your cleared 510(k) premarket notification (K920614) only covers a sterile single use compression arm band, not a non-sterile one.
The HemoBand-NS 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/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The sterilized HemoBand-1M is misbranded under section 502(f)(1) of the Act, 21 U.S.C. 352(f)(1) in that the labeling for the device fails to bear adequate directions for use for the purposes for which it is intended, because it does not contain a warning statement instructing users to listen for bruit (blood flow sound) in the graft. During the original review of K920614, FDA explained that a prominent cautionary statement was necessary, and you provided FDA with the revised labeling that included this warning before FDA cleared the device. However, the labeling on the HemoBand-1M that you currently market fails to bear this warning.
This inspection also 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. We received a response from Hal J. Oien, DMD, Vice President, dated October 30, 2007, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to Dr. Oien. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish procedures for receiving, reviewing, and evaluating complaints, and failure to review, evaluate, and investigate complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications, as required by 21 CFR 820.198(a) and (c).
For example, your firm has received oral complaints but they have not been documented. Your firm provided two packing slips to our investigator dated November 25, 2005, and April 26, 2006, for replacements shipments to one customer due to product breakage. A notation on the invoices for these two shipments stated that your firm had complaints on product breakage. However, you were unable to provide our investigator with any complaint forms or documentation of an investigation of these complaints.
We have reviewed your response and acknowledge that you have provided documentation of your investigation of the April 26, 2006 complaint on May 12, 2006. However, your response is inadequate because you have not provided documentation of an investigation of the November 25, 2005 complaint, and have failed to provide sufficient documentation to verify that the changes to your procedures for receiving, evaluating, and investigating complaints, including evidence of procedure implementation, will prevent these violations from recurring in the future.
2. Failure to establish and maintain data that clearly describes or references the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 21 CFR 820.50(b).
For example, your firm could not present documentation that clearly describes the specified requirements that must be met by [redacted] who packages and sterilizes the HemoBand-1M device. We cannot be assured that the device is manufactured to its specifications without any documentation, nor can you make an evaluation of the process completed by [redacted]
We have reviewed your response and have concluded that it is inadequate because you cannot assure that the device is manufactured to its specifications without any documentation, nor can you make an evaluation of the process completed by [redacted] Your response provided a Vendor Material Certification for two of your firm's suppliers. In this certification, there is a checklist for packaging components but the checklist does not constitute an adequate description of the specific requirements for services to be rendered by the supplier. This checklist also does not provide assurance that the validation of radiation is conducted according to the prescribed method.
3. Failure to establish and maintain procedures for monitoring and control of process parameters for standard processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75(b).
For example, your firm could not present any procedures for monitoring and control of process parameters of radiation sterilization validation and packaging of the device. You could not provide procedures for validation of package integrity or periodic radiation dose audits. [redacted] stated they follow their own quality assurance procedure, but this document was also not available at your firm or referenced in your HemoBand-1M Packaging Profile document.
Your response to this observation appears to be adequate.
4. Failure to validate a process with a high degree of assurance and approve it according to established procedures where the results of the process cannot be fully verified, by subsequent inspection and test, as required by 21 CFR 820.75(a).
For example, your firm did not perform product performance validation following sterilization at the specified dose prior to releasing the HemoBand-1M for distribution, as specified in the [redacted] Also, there was no documentation of product performance validation following sterilization at the dose range of [redacted] kGy received by lots 030230, 031218, 040608, 060512 and 060801.
Your response to this observation appears to be adequate.
5. Failure to establish and maintain acceptance procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d).
For example, during the inspection our investigator found that your firm did not have procedures for final acceptance testing of the HemoBand-1M. The complaint, dated July 1, 2007, noted that there was a broken part among devices you held for distribution but your firm does not conduct final acceptance testing for latch integrity. Dr. Oien told our investigator that your employee wiggled the latch before preparing the device for shipment, but this activity is not documented.
We have reviewed your response and have concluded that it is inadequate because your firm has still not established procedures for acceptance or rejection of finished device production runs, lots, or batches. The "Latch Test" described in the Final Acceptance Record has not been validated for its intended purpose. Additionally, you failed to provide any information regarding the validity of the statistical method chosen.
6. Failure to maintain device master records (DMRs) that include specifications such as appropriate drawings, composition, formulation, component specifications, and software specifications, as required by 21 CFR 820.181(a).
For example, your document entitled "HB Packaging Protocol: 060801" does not include testing of package seals or final acceptance testing. The DMRs fail to include sterilization processing specifications, device specifications such as drawings, or quality assurance procedures such as acceptance criteria.
We have reviewed your response and have concluded that it is inadequate because your firm did not indicate whether all of the elements of the device master record are available at the firm or whether the attachment identified the drawings and quality assurance 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 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 violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23d Drive SE, Bothell, Washington 98021-4421. If you have any questions about the content of this letter please contact Lisa M. Elrand at (425) 483-4913.
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 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 assurance 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.
Charles M. Breen