Inspections, Compliance, Enforcement, and Criminal Investigations
Patterson Technology Center, Inc. 24-Oct-06
Department of Health and Human Services
Public Health Service
October 24, 2006
RETURN RECEIPT REQUESTED
Mr. Jim Wiltz, President and CEO
Patterson Technology Center, Inc.
2202 Althoff Drive
Effingham, IL 62401-4604
Dear Mr. Wiltz:
During an inspection of your firm located in Effingham, Illinois, on May 18, 2006, through May 25, 2006, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures EagleSoft software. 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 because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
This inspection revealed that this device is 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. These violations include, but are not limited to, the following:
l. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198. For example, your firm has not established procedures covering complaint handling.
2. Failure to establish and maintain adequate procedures for implementing corrective and preventive action including analyzing quality data, investigating nonconformities, identifying the actions needed to correct and prevent recurrence of nonconformities, verifying or validating the corrective and preventive actions, implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems, and failure to submit for management review relevant information on identified quality problems as well as corrective and preventive actions, as required by 21 CFR 820.100. For example, your firm reported that none of the above procedures existed.
3. 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.
4. 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 quality system procedures and instructions that show how each element of the quality system requirements is met, as required by 21 CFR 820.20(e).
Your firm failed to establish procedures for management review at appropriate intervals to ensure the effectiveness of your quality system is being adequately met, as required by 21 CFR 820.20(c).
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).
Your firm's management with executive responsibility has failed to appoint, and document such appointment, a member of management who ensures that the quality system requirements are effectively established and maintained in accordance with 21 CFR 820.20(b)(3).For example, your firm's management failed to ensure reporting on the performance of the quality system to management with executive responsibility for its review, as required by 21 CFR 820.20(b)(3)(ii).
5. Failure to establish procedures for quality audits and conduct such audits to ensure that the quality system complies with the established quality system requirements, as required by 21 CFR 820.22. For example, no documented quality audits have been conducted. No written procedures are maintained by your firm for conducting audits of the quality system.
6. Failure to establish and maintain an adequate device master record for the EagleSoft software. Each device master record is required to contain specifications, production process specifications, quality assurance procedures, and installation, maintenance, and servicing procedures, as required by 21 CFR 820.181. For example, there is no formally designated device master record.
7. Failure to maintain procedures to ensure device history records for each batch, lot, or unit are maintained that demonstrate the device is manufacture in accordance with the device master record, as required by 21 CFR 820.184. For example, no device history records have been established to show the finished device conforms to the specifications in the device master record.
8. 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.
9. Failure of management to approve procedures for performing and verifying that servicing meets the specified requirements, as required by 21 CFR 820.200(a). For example, your firm has not established a procedure defining customer service requirements.
10. 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.
11. 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.
12. 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:
13. 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.
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 device have been corrected.
Please notify this office in writing within 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 violation(s), or similar violation(s), 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: Matthew J. Sienko, Compliance Officer, Food and Drug Administration, 550 West Jackson Boulevard, 15th Floor, Chicago, Illinois 60661-5800. If you have any questions about the content of this letter please contact Mr. Sienko at
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 these violations, and take prompt actions to correct these violations and to bring your products into compliance.
Scott J. MacIntire