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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Estill Medical Technologies, Inc. 23-Aug-05

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

Public Health Service
Food and Drug Administration


Dallas District
4040 North Central Expressway
Dallas, TX 75204-3145

August 23, 2005

Ref: 2005-DAL-WL-24



Mr. James T. Lopez, Chief Operating Officer
Estill Medical Technologies, Inc.
4144 N. Central Express, Ste 260
Dallas, TX 75204-3100

Dear Mr. Lopez:

During an inspection of your establishment located in Dallas, Texas, on July 5 through 28, 2005, our investigators determined that your firm is a specification developer that manufactures the TA-200 Thermal Angel® Blood and IV Fluid Infusion Warmer. This product is a device as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). 21 U.S.C. 321(h).

The above-stated inspection revealed that your devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C. 351(h)) because the methods used in, or the facilities or controls used for the manufacturing, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820.

At the close of the inspection, your firm was issued a List of Inspectional Observations, Form FDA-483, which identified a number of significant QS Regulation violations including, but not limited to, those described below.

1. Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to ensure that all the requirements of 21 CFR 820.198(a) through (e) are met [FDA-483 Item 7]. For example:

a) Time frames for the closure of complaints are not defined, and complaints were not always processed in a timely manner. Of the (39) complaints reviewed, (3) open complaints are between 18 and 20 months old and (7) other open complaints are between 7 and 10 months old.

b) Complaints were not always evaluated, reviewed, further followed up with the users, and the results of the evaluation are not documented, to determine whether or not an investigation or a corrective, action is necessary. See Complaint #45, dated September 30, 2003, for blood leak from the device, Complaint #46, dated September 30, 2003, and Complaint #56, dated September 16, 2004, for the malfunctioned devices.

2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, including the identification, documentation, evaluation, and disposition of nonconforming product, as required by 21 CFR 820.90(a) [FDA-483 Items 11, 12, and 13]. For example, neither your firm nor your foreign contract manufacturer maintained records of initial device rejects and subsequent device reworks. Your firm has not established written procedures describing (a) the work flow process (production and process controls and acceptance activities) at your firm, the foreign contract manufacturer, and the foreign contract sterilizer; (b) how nonconforming products are to be evaluated, segregated, and investigated; (c) the need for a notification of the persons or organizations responsible for the nonconformance; (d) who is responsible for review and the authority for the disposition of the nonconforming product; and (e) who maintains records of the nonconformity review and disposition at each stage of the manufacturing processes (e.g . Estill Medical, Inc., the foreign contract manufacturer, and the foreign contract sterilizer).

3. Failure to establish and implement procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d), and to include maintaining acceptance records, as required by 21 CFR 820.80(e) [FDA-483 Item 14]. For example, your firm has no written procedures for acceptance testing (called "AQL" Testing) of the devices, including a check to determine if the operating software was correctly downloaded into the devices and testing the devices for leaks, fluid flow, and heating functions. All acceptance testing instructions and acceptance criteria were verbal in nature and were not documented. The foreign contract manufacturer sends a sample of the devices from a particular lot or batch to your firm for acceptance testing prior to sending the remaining devices to the contract sterilizer for sterilization.

4. Failure to establish and maintain procedures for acceptance or rejection of incoming product, including documentation of the results of acceptance or rejection, as required by 21 CFR 820.80(b) [FDA-483 Item 15]. For example, your firm has not established written procedures for the inspection of incoming products, such as the TA-200 Thermal Angels, rechargeable batteries, battery chargers, power cords, and IV extension tubes.

5. Failure to identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3) [FDA-483 Items 12 and 13]. In your firm's March 10, 2004 evaluation report of the foreign contract manufacturer your firm provided to our investigators, your firm indicated that the foreign contract manufacturer repeatedly "reworked" the rejected devices until they passed your firm's acceptance specifications. Records of reworked devices were not kept, and the reason for rework and any potential adverse effects from the rework upon the product were not documented. As a result, your firm was unable to evaluate and analyze the trend of device rejects or quality issues experienced during the device assembly process at the foreign contract manufacturer. Your firm further acknowledged that neither your firm nor the foreign contract manufacturer had established written procedures for rework of nonconforming devices. At the time of our inspection, your firm has not formulated and documented a corrective action plan to address these noncompliance issues.

6. Failure to establish 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(a) [FDA-483 Item 2]. Your firm failed to (a) review and approve design control procedures, and (b) maintain a design history file or documentation of the design input requirements, design outputs, design verification or validation, design review, and design transfer for the original design of the TA-200 Thermal Angel.

7. Failure to establish and maintain procedures for adequately validating the device design to ensure that the device conforms to user needs and intended uses, including design testing under actual or simulated user conditions, as required by 21 CFR 820.30(g) [FDA-483 Items 4 and 5]. For example:

a) The device's hardware and software features that regulate the fluid flow temperature over the maximum of [redacted] time interval and prevent the device from overheating (a software fail-safe to shut off the device at [redacted] °C and a hardware fail-safe to shut off the device at [redacted] °C with no recovery) were not validated and documented.

b) The hemolysis study conducted to validate that the device will not cause blood hemolysis did not include testing the device at various combination conditions of fluid flow rates and temperatures.

8. Failure to adequately validate manufacturing processes with a high degree of assurance, approve, and document the results of the validation activities to ensure that product specifications can be consistently met, as required by 21 CFR 820.75(a) [FDA-483 Item 3]. Your devices contact blood and are labeled as' sterile devices, but neither your firm nor the foreign contract sterilizer has validated and documented [redacted] the sterilization process. Further, your firm failed to ensure that certain significant manufacturing processes used by the foreign contract manufacturer are identified and validated or provide the justification for not conducting any manufacturing process validation. For example, in your May 23, 2005 e-mail to the foreign contract manufacturer, internal or external leaks appear to be critical defects identified for your devices, but specific manufacturing processes that could cause leaks were not identified, evaluated, and documented.

9. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, including evaluation of suppliers, contractors, and consultants, as required by 21 CFR 820.50 [FDA-483 Items 3 and 6]. Your firm has not established written procedures or written agreements with the foreign contract manufacturer and sterilizer to require (a) procedures for evaluating or auditing the foreign contract manufacturer and sterilizer for their ability to meet your firm's quality requirements; (b) how the devices are to be assembled, tested, reworked, and sterilized to meet your firm's quality requirements and acceptance specifications; (c) how and where the acceptance/rejection test results are to be documented; and (d) who is responsible for maintaining device history records. The absence of written procedures or written agreements is further evident in your firm's May 23, 2005 e-mail to the foreign contract manufacturer that your firm appeared to be concerned about the quality of the devices being shipped to your firm and asked several questions concerning the devices that failed the leak test (e.g., whether devices that failed the leak test were reworked or scrapped, what was the pressure and how long the devices were tested).

We acknowledge receiving your firm's response, dated August 17, 2005, to the Form FDA-483, Inspectional Observations, issued to your firm at the conclusion of our inspection on July 28, 2005. You responded that your firm has addressed each one of the inspectional observations and proposed completion dates ranging from 1 month to 15 months.

Your firm responded that your firm has had quick turnovers of quality assurance employees, and as a result, many documents and procedures were left in an incomplete state. You, as management with executive responsibility, have not (a) explained the reason for quick turnovers of quality assurance employees and why the quality system procedures were either missing or left in an incomplete state in the period of four years of manufacturing; and (b) identified specific remedial actions your firm will take to correct this problem.

Your response to each of the inspectional observations lacks adequate details and explanation for FDA to assess your firm's proposed corrective actions. Overall, your firm's response will remain incomplete until your firm has (a) adequately responded to the warning letter items referenced above and the FDA- 483 inspectional observations; (b) identified and completed all the necessary corrective actions and verified their effectiveness; (c) conducted internal quality audit of your firm and on-site quality audits of the two foreign contract manufacturers in order to identify what quality system procedures and records are missing, are not being followed, or are not adequate at either your firm or the contract manufacturers to ensure that all three firms are in substantial compliance with the QS Regulation and the devices being delivered to your firm meet your firm's specified requirements, including quality requirements; and (d) allocated the necessary resources, including the assignment of trained personnel, for management, performance of work, assessment activities, including internal quality audits, in order to maintain a sustainable state of compliance with the QS Regulation.

Due to the serious nature of the inspectional observations, we suggest your firm use a qualified quality system consultant to help identify any gaps in the quality system at your firm, the foreign contract manufacturer, and the foreign contract sterilizer in order for all three firms to establish and implement complete and comprehensive quality system procedures. We want to remind your firm that foreign or domestic contract manufacturers and sterilizers manufacturing and sterilizing devices for the U.S. market must comply with the quality system regulation and are subject to FDA inspections.

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 the regulations. The specific violations noted in this letter and in the Form FDA-483 may be symptomatic of other serious underlying problems in your firm's manufacturing and quality assurance systems.

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 applications for premarket approval 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 approved until the violations related to the subject devices have been corrected.

You should take prompt action to correct these violations. Failure to promptly correct these violations 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 15 working days of-receipt of this letter of the specific steps you have taken, or will take, to identify and correct the noted violations, including (1) the timeframes 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 ensure that similar violations will not recur.

Your response should be sent to Thao Ta, Compliance Officer, DAL-DO, Food and . Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, TX. 75240. If you have any questions about the contents of this letter, please contact Mr. Ta at 214-253-5217.



Michael A. Chappell
Dallas District Office