Inspections, Compliance, Enforcement, and Criminal Investigations
Visual Telecommunications Network, Inc. 13-Sep-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|Central Region |
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707
September 13, 2005
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Allen Izadpanah, President and CEO
Visual Telecommunications Network, Inc.
8201 Greensboro Drive, Suite 6100
McLean, VA 22102
Dear Mr. Izadpanah:
During an inspection of your firm located in McLean, Virginia from June 28 - July 8, 2005, our investigator determined that your establishment is a medical device specification developer of the ViTelCare™ Turtle™ 800 Home Patient Monitoring System (Turtle 800) and ViTelCare™ Turtle™ 600 Home Patient Monitoring System (Turtle 600), which are medical devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The 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 manufacturer, 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. Furthermore, the devices are misbranded within the meaning of section 502(t) of the Act (21 U.S.C. 352(t)), in that reports required to be submitted to the Food and Drug Administration (FDA) in section 519(a) of the Act (21 U.S.C.360(i)(a)) were not submitted in conformance with the Medical Device Reporting (MDR) procedures found at Title 21 CFR part 803. Significant violations of the QS Regulation and the MDR regulation include:
1. Your firm failed to establish procedures to control design processes of the device.
A. Design control procedures are in the draft stage, and have not been approved. Your firm has manufactured and distributed devices that were designed using these unapproved design control procedures [21 CFR 820.30(a)].
B. Software used in the Turtle 600 and Turtle 800 devices has not been validated and a risk analysis has not been conducted for the finished devices [21 CFR 820.30(g)].
C. Your firm has no assurance that the device design has been correctly transferred into production specifications. Your firm could not provide procedures for qualifications of the master hard drive actually used in production of finished devices [21 CFR 820.30(h)].
D. Your firm's design plan does not include information regarding who is responsible for implementing design and development activities [21 CFR 820.30(b)].
2. Your firm failed to establish quality system procedures. Specifically, quality system procedures have not been reviewed and approved. [21 CFR 820.20(e)].
3 . Your firm failed to establish procedures addressing documentation of corrective actions and preventive action activities:
A. Current corrective and preventive action procedures have not been approved [21 CFR 820.100(a)].
B. Your firm's "Corrective and Preventative Actions (CAPA) Policy" mentions "trend Identification" and "statistical analysis" but no procedure exists that describes how trending or statistical analysis are to be accomplished [21 CFR 820.100(a)(1)].
C. Your firm's current quality data collection is limited to help desk calls and other phone conversations with customers. Other quality data, such as that from component and finished device failures, are not being collected [21 CFR 820.100(a)(1)].
D. Your firm has no procedures regarding product corrections, removals, or recalls. Your firm has recently instructed a customer to return fourteen Turtle 800 telemedicine devices for corrections and repairs, including replacement of electronic components. Your firm has no system in place to evaluate whether or not these types of actions should be reported to FDA [21 CFR 806.10].
E. Your firm has no procedures governing dissemination of data regarding non-conforming products, quality problems, corrective actions, or preventative actions, either to employees for analysis or to upper management for review [21 CFR 820.100(a)(6) & (7)].
F. Your firm is not documenting the disposition of all devices returned for repair [21 CFR 820.100(a)(5) & (b)].
4. Your firm failed to establish procedures for conducting quality audits. Specifically, your firm has no internal audit procedures and you have not appointed anyone to be responsible for conducting internal audits [21 CFR 820.22].
5. Your firm failed to develop written medical device reporting (MDR) procedures. Specifically, your firm has no MDR procedure, and does not have a system in place to evaluate whether or not medical device reports should be filed with FDA [21 CFR 803.17].
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence with applicable laws and regulations. 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.
We are in receipt of your written response, dated August 4, 2005, to the Form FDA-483 issued at the close of the inspection. We acknowledge that you have promised to address the issues cited in the FDA-483, including conducting validation studies on the Turtle 600 and 800, validating that the software meets its intended clinical purpose, and creating a "new QSR manual". You have also promised to establish an executive review and .approval process along with other procedures and policies. Nevertheless, your response by itself is inadequate to address the violations discussed above because you must properly implement, document, and maintain each corrective action to ensure its effectiveness. Further, we cannot determine whether the procedures you have promised are adequate without reviewing the documentation. We would appreciate receiving copies of the documentation of all the procedures and policies that you have promised.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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 penalties.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the steps you have taken to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur.
Your response should be sent to Randy F. Pack, Compliance Officer, Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions, please do not hesitate to contact Mr. Randy F. Pack at (410) 779-5417.
Acting District Director
Baltimore District Office