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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Steritec Products, Inc. 17-Oct-08

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

Public Health Service
Food and Drug Administration


Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 2508 7
6th Avenue & Kipling Street
Denver, Colorado 80225-0087

Telephone: 303-236-3000
FAX: 303-236-3551

October 17, 2008



Mr. Thomas R. Roll
Steritec Products, Inc.
599 Topeka Way, Suite 400
Castle Rock, CO 80109

Ref # DEN-09-01

Dear Mr. Roll:

During the period April 29 through May 15, 2008, an investigator from the U.S. Food and Drug Administration (FDA) conducted an inspection of your establishment. Our investigator determined that your firm manufactures sterility assurance disposable indicators, including the Flash Integrator. These products are medical devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act(the Act), [21 U.S.C. § 321(h)].

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. Significant violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for acceptance of incoming components. Incoming product and components must be inspected, tested, or otherwise verified as conforming to specified requirements, 21 C.F.R 820.80(b).

Specifically, you accepted an incoming lot of (b)(4) used in the manufacture of the Flash Integrator sterility indicator, without testing to assure that the new lot had the same performance characteristics as the (b)(4) used in designing and developing the device. This resulted in your market withdrawal of three lots of the Flash Integrator because of complaints that the device was failing to meet its performance specification of changing color in a three-minute sterilization cycle.

We acknowledge receipt of your June 16, 2008 response to our Form FDA 483 issued on May 15, 2008. Your response to this item appears to be addressing our concerns, but will be reviewed and fully evaluated during our next inspection of your firm.

2. Failure of your design output procedures to contain or make reference to acceptance criteria for incoming linseed oil, 21 C.F.R. 820.30(d).

Your June 16, 2008 response is inadequate because you did not provide a copy of your new (b)(4) Qualification Protocol.

3. Failure to establish and maintain procedures for conducting design reviews, validating device design and validating design changes, 21 C.F.R. 820.30(e) & (g) & (i).

Specifically, you failed to follow your procedures: (b)(4) SteriTec Integrator Flash, Integrator Validation Protocol and Test Results (b)(4) SteriTec Integraph Flash, Self-Life Validation Protocol and Test Results; and (b)(4) Product Design Review Procedure. In addition, you did not validate design change, Change Order No (b)(4)

Your June 16, 2008 response to this item is inadequate in that you stated you had provided Design Control Training to your employees, but did not provide documentation.

4. Failure to establish and maintain 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, 21 C.F.R. 820.22.

Specifically, no quality audit was conducted in the calendar year 2005. Following the 2006 quality audit, you failed to document the audit on form (b)(4) as per your procedure (b)(4) Facility Audit Procedure.

Your June 16, 2008 response appears to be addressing our concerns, but your corrective actions will be reviewed and fully evaluated during our next inspection of your firm.

5. Failure of management with executive responsibility to establish and maintain a quality system that is appropriate for the specific medical device designed or manufactured, 21 C.F.R. 820.5.

Specifically, you have not established a complete quality system including management controls, design controls, process validation, acceptance activities and corrective and preventive action.

6. Failure to establish and maintain procedures for implementing corrective and preventive actions; 21 C.F.R. 820.100.

Specifically, there was no documentation that management reviewed the Corrective and Preventive Action, (b)(4) which pertains to a complaint that the Flash Integrator device was not performing to specifications.

Your June 16, 2008 response appears to have adequately addressed the deviation.

7. Failure to validate a process whose results cannot be fully verified by subsequent inspection and testing, 21 C.F.R. 820.75(a).

Specifically, you manufactured the Flash Integrator device under Change Order, (b)(4)(b)(4) without validating the change.

Your June 16, 2008 response is inadequate for this deviation, because you did not provide documentation of your validation activities for this change order.

Your responses to form FDA 483 items 1, 7, 13 and 14 appear to be adequate.

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, 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.

Failure to promptly correct these violation(s) may result in regulatory action being initiated by the Food and Drug Administration without further notice limited to, seizure, injunction; and/or civil money penalties. These actions include, but are not. 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.

Please notify this office in writing within fifteen (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: Food and Drug Administration, Denver District, P.O. Box 25087, Denver, CO 80225-70087, Attention: William H. Sherer, Compliance Officer. If you have any questions about the content of this letter please contact Mr. Sherer at (303) 236-3051.

Sincerely yours,


H. Thomas Warwick
Denver District Director