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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Westone Laboratories, Inc. 22-May-06

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

Public Health Service
Food and Drug Administration


Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421

Telephone: 425-486-8788
FAX: 425-483-4996



In reply refer to Warning Letter SEA 06-31

Randall T. Morgan, President and CEO
Westone Laboratories, Inc.
P.O. Box 15100
Colorado Springs, CO 80935-9836


Dear Mr. Morgan:

On March 24 and 29, 2006, a Food and Drug Administration (FDA) investigator conducted an inspection of your establishment, located at 248 Southwest 43rd Street, Renton, Washington, and determined that your establishment is a manufacturer of custom fit hearing protection devices. Hearing protection devices are defined as medical devices under 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 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, the 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 (QS) Regulation, as specified in Title 21, Code of Federal Regulations (CFR), pt. 820. Your devices are also misbranded within the meaning of section 502(t)(2) of the Act (21 U.S.C. § 352(t)(2)) because your firm failed to establish and maintain written medical device reporting (MDR) procedures, as required by section 519 of the Act (21 U.S.C. § 360i) and the MDR Regulation, 21 CFR pt. 803.

Significant deviations observed during the inspection include the following:

Quality System Regulation

1. Management has not assured that an adequate and effective quality system was implemented to fulfill the requirements of 21 CFR 820.20.

a. There was no quality plan which defined the quality practices, resources, and activities relevant to your devices (21 CFR 820.20(d)).

b. Quality system procedures were not established (21 CFR 820.20(e)).

c. Management with executive responsibility did not review the suitability and effectiveness of your firm's quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of the Quality System Regulations and the specific requirements of your policy and objectives (21 CFR 820.20(c)).

2. Procedures were not established for quality audits and audits were not conducted to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system (21 CFR 820.22)).

3. Procedures were not established and maintained for implementing corrective and preventive actions (21 CFR 820.100(a)).

4. Complaint handling procedures for receiving, reviewing, and evaluating complaints have not been established (21 CFR 820.198(a)).

5. Acceptance activities are not documented to include the acceptance activities performed, the date acceptance activities are performed, the results, the signature of the individual conducting the acceptance activities, and-where appropriate, the equipment used (21 CFR 820.80(e)).

6. Procedures were not established to ensure that all purchased or otherwise received product and services conform to specified requirements (21 CFR 820.50).

7. Procedures were not established for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, and to document training (21 C.F.R. 820.25(b)).

Medical Device Reporting (MDR)

8. Written MDR procedures were not developed, maintained, and implemented (21 CFR 803.17).

This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by the 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 the violations and take prompt actions to correct the violations and to bring your products into compliance.

We acknowledge receipt of a written response dated April 17, 2006, from Glen W. Roberts, Quality Manager, which responds to the FDA 483 issued at the conclusion of the inspection. While we appreciate your stated commitment to resolving the observed deviations, we have reviewed your response and have determined that it is inadequate. The response indicates that you will begin implementing your quality system over the next few months. No supporting documentation for the new quality system was included. Additionally, the response did not describe any proposed corrective or preventative actions to prevent the recurrence of the deficiencies. Because we have determined that the deficiencies found during our inspection are serious deficiencies from the QS Regulation, you must take immediate action to ensure that the devices manufactured at your facility are in compliance with all applicable QS Regulation

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 submissions for Class III devices to which QS Regulation deficiencies are reasonably related will be cleared 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 deviations. Failure to promptly correct these deviations 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 money penalties.

Please notify this office within 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 identify and make corrections to any underlying system problems necessary to ensure that similar violations will not recur. Please include any and all documentation to show that adequate correction has been achieved. In the case of future corrections, an estimated date of completion, and documentation showing plans for correction should be included with your response to this letter.

Please send your reply to the Food and Drug Administration, Attention: Lisa M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Althar at (425) 483-4940.



Charles M Breen
District Director