|Subject:||CGMP for Medical Devices/QSR/Adulterated/Misbranded|
|Issuer:||Detroit District Office|
|Issued:||June 16, 2008||Closed:||
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
June 16, 2008
Roman S. Ferber
3000 N. Pontiac Trail
Commerce Township, Michigan 48390-2720
Dear Mr. Ferber:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the TheraP™ Deluxe Automatic Blood Pressure Monitor and Therapist Select™ Massagers (that incorporate massage and infrared heating) in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, the TheraP™ Deluxe Automatic Blood Pressure Monitor and Therapist Select™ Massagers (that incorporate massage and infrared heating) 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, 21 U.S.C. 321(h). The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
A review of our records and your website, www.homedics.com (where your firm offers its devices for sale), reveals that you have not obtained marketing approval or clearance before you began offering your TheraP™ Deluxe Automatic Blood Pressure Monitor and Therapist Select™ Massagers (that incorporate massage and infrared heating) for sale, which is a violation of the law.
Your website makes the claim "Irregular Heartbeat Detector for better health monitoring" for the TheraP™ Deluxe Automatic Blood Pressure Monitor. This claim is a new intended use and not covered by your original 510(k) clearance, K020897, and is a major modification to the intended use of this device that requires submission of a new 510(k) in accordance with 21 CFR § 807.81(a)(3). As a result, the TheraP™ Deluxe Automatic Blood Pressure Monitor device is misbranded under section 502(o), 21 U.S.C. § 352(o),in that a notice or other information respecting the new intended uses of the device was not provided to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k). The TheraP™ Deluxe Automatic Blood Pressure Monitor is also adulterated within the meaning of 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), when it is promoted for the new intended use, because you do not have an approved application 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g).
Our office requests that HoMedics immediately cease the use and dissemination of promotional materials for the TheraP™ Deluxe Automatic Blood Pressure Monitor which is the same or similar to that described above.
Your Therapist Select™ Massagers (that incorporate massage and infrared heating) are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have have an approved application 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The Therapist Select™ Massagers (that incorporate massage and infrared heating) are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). Devices that incorporate infrared heating, such as your Therapist Select™ Massagers, are classified as an Infrared lamp under 21 CFR § 890.5500 and require a 510(k).
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.
In addition to the violations discussed above, during an inspection of your firm's facility located in Dongguan, China (HoMedics China) on August 27, 2007, through August 30, 2007, an investigator from the FDA determined that your firm is responsible for manufacturing heating pads, paraffin baths, and blood pressure monitors. Under section 201(h) of 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 (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 21 CFR § 820.50(b). For example:
a. There are no written agreements or other purchasing data between your firm's facility located in Commerce Township, Michigan (HoMedics Michigan) and HoMedics China prescribing who is responsible for developing and implementing various aspects of the quality system regulations. Your Quality Assurance (QA) Manager for HoMedics China stated that he does not have authority to implement anything and only does what HoMedics Michigan tells him to do.
b. There are no written procedures or other purchasing data between HoMedics China and HoMedics Michigan prescribing who is responsible for developing, implementing, and controlling the Device Master Record (DMR).
c. There are no written agreements or other purchasing data between HoMedics Michigan, HoMedics China, and the three contract manufacturers [redacted] indicating who has authority for lot release and distribution and how the release is to be implemented and controlled. Your HoMedics China QA Manager stated that the current agreement between HoMedics China and the three contract manufacturers has not been formalized.
d. There are no written agreements or purchasing data between HoMedics Michigan, HoMedics China, and the three contract manufacturers established to document, exchange, and coordinate the handling, investigating and analyzing of nonconforming data, complaints and corrective and preventive actions.
2. Failure to establish and maintain adequate DMR's in accordance with 21 CFR § 820.40, including, but not limited to, adequate quality assurance procedures and specifications, as required by 21 CFR § 820.181.
For example, there is no documentation or evidence of review and approval by HoMedics Michigan of the inspection file entitled "QA Specification for BPW-410WGN Wrist blood pressure monitor," which was created and implemented by your HoMedics China QA Manager [redacted] is responsible for the design of this device, however, there is no documentation that the quality assurance specifications developed by HoMedics China are in accordance with the device specifications and production specifications developed and approved by [redacted]. Furthermore, there is no documentation of who is designated to review and approve the inspection file specifications.
3. Failure to establish an d maintain adequate procedures for acceptance activities, including, but not limited to, inspections and tests, as required by 21 CFR § 820.80(a).
For example, the inspection tests report for your heating pads, dated December 23, 2006, is a completed inspection report for finished device testing of model [redacted] includes the following items that were crossed out by you HoMedics China inspector:
a. The specifications for wattage draw under item 4 are crossed out and a specification for the [redacted] is written in by hand.
b. The specifications for resistance check under item 5 are crossed out and a specification for the [redacted] is written in by hand.
c. The specifications for [redacted] and the second specification for the [redacted] are crossed out; a different specification for [redacted] as written in by hand.
d. The specifications for [redacted] (item 7) [redacted] (item 11), and [redacted] are completely crossed out and were no tested for this model of heating pad.
These changes to the inspection procedure were not initialed and there was no other record of approval of these changes.
4. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, including, but not limited to, the authorization of release for distribution by the signature of a designated individual, as required by 21 CFR § 820.80(d). For example:
a. There are no procedures that establish the criteria for accepting or rejecting a production run if there are products found to have critical, major, or minor defects. Your HoMedics China Senior Inspector stated that she rejects a lot when there is [redacted] critical defect, but there is no documentation of the procedure use by other inspectors.
b. There are no procedures that define what represents critical, major, and minor defects for the paraffin baths and blood pressure monitors. For example, the inspection report for your automated wrist blood pressure monitors, dated July 28, 2007, documents the finding of "no blood pressure function" as [redacted] defect as opposed to [redacted] defect.
c. There are no written procedures established between HoMedics Michigan, HoMedics China, and the three contract manufacturers, prescribing the specifications and sampling for the finished device testing and acceptance testing, and no procedures prescribing the necessary acceptance records required for these activities. Furthermore, there are no procedures established between the three parties to ensure the review and approval of all activities required in the DMR and to ensure the Device History Record demonstrates the devices were manufactured in accordance with the DMR.
d. The procedure "Shipment Inspection Procedure - China [redacted] discusses final lot release procedures, but it has not been formally reviewed and approved.
e. The procedure "Shipment Inspection Procedure - China, [redacted] section [redacted] states that the QA Manager or the Chief Inspector is responsible for reviewing and approving the inspection report within [redacted] days of completing the form. Inspection reports for heating pads, paraffin baths, and wrist blood pressure monitors are signed by your QA Manager but there are no signature dates. Without including a date for the review and approval, it is unclear if inspection reports are reviewed and approved prior to lots being released for distribution.
f. HoMedics China releases products for distribution using signed QA shipment release notes that are either faxed or e-mailed to the contract manufacturers. Review of the QA shipment release notes from the last two (2) years documented that none were signed. Additionally, no documentation that the QA shipment release notes were faxed or e-mailed to the contract manufacturers exists; nor is there any documentation of receipt by the contract manufacturers.
5. Failure to establish and maintain procedures to control documents and ensure that designated individual(s) review for adequacy and approve prior to issuance all documents established to meet the quality system regulations, as required by 21 CFR § 820.40(a). For example:
a. There are no written document control procedures established and implemented at HoMedics China. Furthermore, HoMedics Michigan has not approved, with a signature, any quality system documents to verify review and approval. Your HoMedics China QA Manager stated that currently they only e-mail quality system documents to their supervisor at HoMedics Michigan asking for approval, and then receive an e-mail in response either granting or denying approval. HoMedics China maintains one [redacted] these unsigned e-mails for each manufacturer.
b. The procedure "Shipment Inspection Procedure - China" [redacted] has not been formally reviewed and approved. Your HoMedics China Wanager prepared, signed, dated, and implemented this document. However, HoMedics Michigan has not documented review and approval. Although it appears your HoMedics Michigan QA Manager is responsible for all document controls, there is nothing documenting this or what documents the HoMedics Michigan QA Manager has authority over.
c. Your HoMedics China QA Manager stated that if he receives new inspection report documents via e-mail from HoMedics Michigan, he destroys the previous editions and issues "the new inspection report documents to the inspectors. However, it could not be determined which inspection report was current. Furthermore, it appears that HoMedics Michigan e-mailed the original inspection report documents to HoMedics China with no documentation of approval.
6. Failure to maintain records of changes to documents including the description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective, as required by 21 CFR § 820.40(b).
For example, your firm does not maintain revision control. The inspection report for a blood pressure monitor (model BPW-41OWGN), QA Report No. [redacted] dated August 6, 2007, specifies "Revision 2" on the bottom of page one. However, there are no records indicating when revision 2 was implemented.
7. Failure to establish and maintain procedures for identifying valid statistical techniques to ensure that sampling methods are adequate for their intended use and to ensure that sampling plans are reviewed when changes occur, as required by 21 CFR § 820.250(b). For example:
a. There is not a documented statistical rationale for the sampling plan used for final release testing and inspection, and there are no documented procedures to ensure that the sampling methods are adequate for their intended use.
b. There are no documented procedures on how to select a random sample. Specifically, it is up to the inspectors to randomly sample the amount they need to complete their inspection report.
c. There are no procedures to ensure that sampling plans are reviewed when changes occur. Specifically, there are no procedures to explain or describe when to increase or decrease the acceptable quality limit (AQL) for inspections when changes in acceptance or failure rates occur.
8. Failure to ensure that all personnel are trained to adequately perform their assigned responsibilities and to document training, as required by21 CFR § 820.25(b)
For example, HoMedics China did not document training of personnel on the new inspection report procedures prior to implementation. The inspector training procedure, "Training Procedures for New Inspectors - China," [redacted] date August 4, 2007, requires training on changes to product specifications, test requirements, and inspection reports in sections [redacted] and [redacted] Section [redacted] requires that each inspector's training record be updated to reflect this training.
Given the serious nature of the violations of the Act, your devices are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your response is adequate, and we may need to re-inspect your facility to verify that the appropriate corrections have been made. An FDA representative will contact the appropriate responsible individuals at your firm to arrange a mutually convenient date for this inspection.
You should take prompt action to correct these violations. 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/or civil money penalties.
Also, U.S. 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.1 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. Please provide a translation of documentation not in English to facilitate our review.
Your response should be sent to: Judith A. Putz, Compliance Officer at the above address.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations. 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 items discussed at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems, and in your firm's marketing of devices without marketing, clearance or approval. 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.
Joann M. Givens
Detroit District Office
1 Please note that you have been copied on Warning Letters received by your contract manufacturers [redacted]