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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Thermoplastic Comfort Systems, Inc. 21-Sep-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900



September 21, 2006

W/L 42-06

Marilin S. Posca, President
Thermoplastic Comfort Systems, Inc.
2619 Lima Avenue
Signal Hill, CA 90755

Dear Ms. Posca:

During an inspection of your establishment located in Irvine, California, on August 8 through August 14, 2006, our investigator determined that your firm manufactures dental devices and resins intended for dental relining, repairing, and rebasing. These products are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), because they are intended for use in the cure, treatment, prevention, or diagnosis of a disease or medical condition, or are intended to affect the structure or any function of the body.

The above-stated inspection revealed that these devices are adulterated under 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 conformance with the Current Good Manufacturing Practice(CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following:

1. Failure to ensure that management with executive responsibility has established an adequate and effective quality system that is fully implemented and maintained at all levels of the organization as required by 21 CFR 820.20(d). Specifically, there is no documentation describing any quality planning activities conducted or how the requirements for quality will be met.

2. Failure to ensure that organization structure is adequate to ensure that quality systems are effectively established and maintained as required by 21 CFR 820.20(b)(3). Specifically, the President identified herself as the management representative responsible for quality system requirements, even though she also acknowledged that she was unfamiliar with FDA's quality system regulations. Under the firm's structure, the President, as management representative, would report to herself, as management with executive responsibility for review, under 21 CFR 820.20(b)(3)(ii).

3. Failure to implement and control procedures for management reviews as required by 21 CFR 820.20(c). Specifically, management reviews are not conducted at defined intervals to ensure that all requirements of the quality system are satisfied; and all quality system requirements are not reviewed for effectiveness.

4. Failure to ensure that quality audits are conducted to verify that the quality system is effective in fulfilling all quality system objectives as required by 21 CFR 820.22. Specifically, there have been no internal quality audits performed since the formation of the organization in 2002 even though your management review procedure requires an internal audit at least annually.

5. Failure to ensure that training procedures identifying training needs are implemented and training activities are documented as required by 21 CFR 820.25(b). Specifically, no training records are created or maintained.

6. Failure to establish, implement, and control procedures for Corrective Action and Preventive Action (CAPA) as required by 21 CFR 820.100. Specifically, no corrective and preventive actions have been documented or procedures implemented to require: appropriate analysis of quality data to identify causes of non-conformities and other quality problems; investigation into the cause of non-conformities; and identification of actions needed to correct or prevent the recurrence of non-conformities.

7. Failure to establish, implement, and maintain procedures to control the design of the device in order to ensure that specified design requirements are met as required by 21 CFR 820.30. Specifically, there are no procedures for design development and planning, design inputs, design outputs, design reviews, design changes, design validations, design verifications, and design transfer.

8. Failure to implement and control procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50. Specifically, no records of inspection and/or testing are maintained.

9. Failure to establish, implement, and control procedures to ensure that equipment used in production and measuring of devices are routinely calibrated, inspected, and checked for accuracy, as required by 21 CFR 820.70(g) and 820.72. Specifically, no records are maintained for the inspection, checking, adjustment and calibration of scales, production furnace, and filling machine.

10. Failure to establish, implement, and control procedures for the validation of production processes and control and monitoring of process parameters as required by 21 CFR 820.75. Specifically, there is no process validation procedure nor have any validation activities been performed for the manufacturing of TCS unbreakable devices.

11. Failure to establish, implement, and control procedures for acceptance activities to include inspections, tests, or other verification activities as required by 21 CFR 820.80(e). Specifically, there are no records of acceptance activities of raw materials, in-process materials received, or finished devices manufactured by the firm.

12. Failure to properly establish, implement, and control procedures for product that does not conform to specified requirements as required by 21 CFR 820.90. Specifically, the firm's written procedure for handling of non-conforming material does not require the firm to investigate and evaluate non-conformities.

13. Failure to establish, implement and control procedures to ensure that device history records for each batch or lot or units are maintained to demonstrate that the device is manufactured in accordance with Device Master Record (DMR) as required by 21 CFR 820.184. Specifically, there are no procedures for the creation and maintenance of device history records for production of devices.

14. Failure to ensure complaint files are maintained and that all oral and written complaints are documented upon receipt and are processed in a uniform and timely manner as required by 21 CFR 820.198. Specifically, the firm maintains no complaint files and does not document telephone inquires about devices not meeting their quality attributes.

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your quality system.

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 approval applications for Class III devices to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be granted 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.

Please notify this office in writing within fifteen (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 prevent the recurrence of similar violations. 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.

If you have any questions relating to this letter please contact Senior Compliance Officer, Dannie E. Rowland at 949-608-4448. You may obtain general information about all of FDA's requirements for manufacturers of medical devices through the Internet at http://www.fda.gov.

Please submit your response to:

Pamela B. Schweikert
Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2445



Alonza E. Cruse
District Director
Los Angeles District Office