Recipient: Patterson Technology Center Inc.
Product:EagleSoft software
Date:10/24/06
Failure to maintain procedures for receiving and evaluating complaints by a fomally designated unit; failure to establish and maintain adequate procedures for implementing corrective and preventive action; failure to establish and maintain adequate design control procedures to ensure design procedures address the planning, inputs, outputs, review, verification, validation, transfer, and changes to the software to user needs and intended uses; failure of management with executive responsibility to ensure that an effective quality system has been implemented at all levels of the organization; failure to establish procedures for and to conduct quality audits; failure to establish and maintain an adequate device master record; failure to maintain procedures to ensure device history records for each batch are maintained; failure to establish and maintain procedures for acceptance activities; failure of management to approve procedures for performing and verifying that servicing meets requirements; failure to establish and maintain procedures to control approval, distribution and changes to documentation; failure to establish written purchasing procedures for evaluating suppliers, contractors, consultants, and purchasing data and agreements; failure to document employee training; and failure to develop and implement written Medical Device Reporting requirements.
Failure to establish and maintain adequate design control procedures to ensure design procedures address the planning, inputs, outputs, review, verification, validation, transfer, and changes to the EagleSoft software to user needs and intended uses, as required by 21 CFR 820.30. For example, there is no formally approved documentation for design control procedures or documented validation of the EagleSoft software performed by your firm.
Management with executive responsibility has not fully implemented and maintained at all levels of the organization its policy and objectives for a commitment to quality for the production of the EagleSoft software used for dental image manipulation and storage, as required by 21 CFR 820.20. For example:
Your firm failed to establish a quality plan that defines the quality practices, resources, and activities relevant to your EagleSoft software, as required by 21 CFR 820.20(d).
Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80. For example, your firm has not established procedures for acceptance of EagleSoft software being burned onto compact disks by an outside vender.
Failure to establish and maintain procedures to control approval, distribution, and changes to documentation, as required by 21 CFR 820.40. For example, your firm has not established and maintained procedures to control the approval, distribution, and changes to documents for your EagleSoft software device.
Failure to establish written purchasing procedures for evaluating suppliers, contractors, consultants, and purchasing data and agreements, as required by 21 CFR 820.50. For example, supplier requirements, evaluation activities, and other purchases pertaining to EagleSoft software.
Failure to ensure that employee training is documented, as required by 21 CFR 820.25(b). For example, there is no documented training for quality assurance personnel who inspect and test EagleSoft software.
Our inspection also revealed that your EagleSoft software device is 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 is required by or under Section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR) regulation. A significant deviation includes, but is not limited to, the following:
Failure to develop, maintain, and implement written medical device reporting (MDR) requirements for identifying, evaluating, reviewing, and submitting timely reports of events that may be subject to medical device reporting, as required by 21 CFR 803.17. For example, your firm has not established any written MDR procedures
FDA District: Chicago District Office
