Inspections, Compliance, Enforcement, and Criminal Investigations
ConnexMD, Inc. 03-Jan-08
Department of Health and Human Services
Public Health Service
January 3, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-07
Curtis L. LeBleu, President
8536 18th Avenue NW
Seattle, Washington 98117
Dear Mr. LeBleu:
During an inspection of your firm located at 8536 18th Avenue NW, Seattle, Washington, conducted on October 15-16, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the EchoConnex Communicator software (Digital-Image Storage and Review) which is used in hospitals, imaging centers, and office practices. 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 that is 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 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 C.F.R. § 820.22. You could not provide any documented quality audit procedures during the inspection.
2. Failure to have management review of the suitability and effectiveness of the quality system, as required by 21 C.F.R. § 820.20(c). You have not established management review procedures.
3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 C.F.R. § 820.100(a). You have no documented corrective and preventive action (CAPA) procedures.
4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints, as required by 21 C.F.R. § 820.198(a). You presented a draft document during the inspection that dealt with complaints; however, it was not finalized.
5. Failure of a formally designated unit to maintain records of investigations made under 21 C.F.R. 820.198, and a failure to include the dates and results of the investigation in the records, as required by 21 C.F.R. § 820.198(e)(6). You presented to our investigator a list of reported problems. that you have received, but there is no documentation of the actual investigation of these problems.
In addition to the above-noted violations, our investigator documented that your firm has not established Medical Device Reporting (MDR) procedures for your device, as required by 21 C.F.R. § 803.17. The failure or refusal to furnish material or information respecting a device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803 the MDR regulation, causes the device to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2).
This letter is not intended to be an all-inclusive list of 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.
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, no premarket submissions for Class III devices to which QSR deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for-Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected.
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 within 15 working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying system problems necessary to ensure that similar violations will not recur. Please include any and all documentation to show that adequate correction has been achieved. In the case of future corrections, an estimated date of completion, and documentation showing plans for correction should be included with your response to this letter.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23d Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483-4913.
Charles M. Breen