Company: Westone Laboratories Incorporated
Subject: CGMP/QSR/Medical Devices/Adulterated
Issuer: Denver District Office
Issued: Oct. 23, 2012 Closed: Sept. 10, 2013
Source ucm326927 Archive Code:

Westone Laboratories Incorporated 10/23/12

Department of Health and Human Services

Public Health Service
Food and Drug Administration

Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3551

October 23, 2012



Mr. Lynn O. Kehler
President and CEO
Westone Laboratories Incorporated
2235 Executive Circle
Colorado Springs, Colorado 80906

Ref: #DEN-13-02

Dear Mr. Kehler:

During an inspection of your firm located in Colorado Springs, Colorado, on July 2, 10, and 12, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Oto-Ease, a patient lubricant.  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 to affect the structure or any 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 its manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.  Your firm’s response dated September 6, 2012, to the Form FDA 483 (FDA 483) issued at the close of the inspection was not reviewed because it was not received within fifteen business days of issuance.  The response may be evaluated along with any other written material provided in response to the violations cited in this Warning Letter.  These violations include, but are not limited to, the following:

1. Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.  For example, your firm failed to establish and maintain quality requirements for suppliers of bulk lubricant or contract manufacturers of containers.  Specifically, your firm failed to:

a) Evaluate potential suppliers on the basis of their ability to meet specified requirements for Oto-Ease;
b) Establish or maintain records of acceptable suppliers of Oto-Ease packaging materials or contract manufacturers of lubricant; and
c) Establish or maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services, and that include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device.

According to your firm, most suppliers were "grandfathered in" in 2006, and do not require contracts.  No requirements, evaluations, or contracts with suppliers were available for review at the time of this inspection.

2. Failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).  For example, your firm has no procedure or process in place to ensure that:

a) All complaints related to Oto-Ease are processed in a uniform and timely manner;
b) Oral complaints related to Oto-Ease are documented upon receipt; and
c) Complaints related to Oto-Ease are evaluated to determine whether the complaint represents an event that is required to be reported to the FDA.

No records are kept regarding complaints or concerns with Oto-Ease because your firm does not consider Oto-Ease to be a medical device.

3. Failure to establish and maintain adequate procedures for acceptance activities, which include inspections, tests, or other verification activities, as required by 21 CFR 820.80(a).  For example, your firm failed to document acceptance activities for receiving, in process, and finished Oto-Ease products.  There is no documentation of the following:

a) The acceptance activities performed on Oto-Ease;
b) The dates the acceptance activities were performed on Oto-Ease;
c) The results of acceptance activities performed on Oto-Ease; and
d) The signature of the individual(s) conducting the acceptance activities on Oto-Ease.

There are no criteria that the bulk lubricant from your firm’s supplier must meet prior to being accepted into inventory.

4. Failure to establish and maintain procedures to control environmental conditions that could reasonably be expected to have an adverse effect on product quality and failure to periodically inspect environmental control systems to verify that the systems are adequate and functioning properly, as required by 21 CFR 820.70(c).  For example, your firm failed to establish environmental control procedures to ensure that the materials, production processes, and assembly area for Oto-Ease are kept free of potential contaminants. The packaging process is not performed aseptically, nor is there documentation to indicate that the fill machine or assembly room are cleaned, sanitized, and/or maintained in a manner that would prevent the introduction of contaminants into the product.

5. Failure to establish and maintain adequate schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met, as required by 21 CFR 820.70(g)(1).  For example, according to your firm, the filling machine used for dispensing bulk lubricant into individual Oto-Ease bottles is not adjusted, cleaned, or maintained according to any documented schedule or procedure.

6. Failure to establish and maintain adequate procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups, as required by 21 CFR 820.60.  For example, when the bulk lubricant is moved from the warehouse to the assembly area and packaged into individual bottles, only the exterior of the 12-pack bottle packages are marked (b)(4) . The individual bottles, the 3-pack bottle packages, and the singlets are not marked with the lot code or contact information for Westone.

7. Failure to establish and maintain adequate procedures to control all documents, as required by 21 CFR 820.40.  For example, your firm does not have procedures to control all required Oto-Ease documents.

8. Failure to maintain device master records (DMRs) and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181.  For example, your firm failed to establish and maintain DMRs for Oto-Ease.  During the inspection, there was no documentation of the following:

a) Oto-Ease device specifications including composition, formulation, or component specifications;
b) Oto-Ease production process specifications including appropriate equipment specifications for the filling machine, production methods, production procedures, and production environment specifications;
c) Quality assurance procedures and specifications including acceptance criteria;
d) Packaging and labeling specifications for Oto-Ease; and
e) Installation, maintenance, and servicing procedures and methods for the fill-line used to package Oto-Ease.

9. Failure to establish and maintain adequate procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR, as required by 21 CFR 820.184.  For example, your firm failed to establish and maintain procedures to ensure that DHRs for each batch of Oto-Ease product are maintained to demonstrate that Oto-Ease is manufactured in accordance with the DMR. Specifically, there is no documentation of the following:

a) The dates of manufacture for Oto-Ease lubricant (in any size);
b) The acceptance records that demonstrate that Oto-Ease is manufactured in accordance with the DMR;
c) The primary identification label (bottle) and labeling used for each production unit of Oto-Ease; and
d) Any Oto-Ease device identifications and control numbers used.

10. Failure to establish adequate procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).  For example, no training needs have been identified for production employees responsible for staging, filling, and packaging the Oto-Ease bottles.  Additionally, training documents demonstrating that production employees have been trained do not exist.  During the inspection, your firm stated that the production employees in the assembly area receive on-the-job training from senior employees, but that no documentation of this training is kept.

Our inspection also revealed that Oto-Ease is adulterated under section 501(f)(1)(B) of the Act [21 U.S.C. § 351(f)(1)(B)] because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act [21 U.S.C. § 360e(a)] or an approved application for an investigational device exemption under section 520(g) of the Act [21 U.S.C. § 360j(g)].  The device is also misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)] because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act [21 U.S.C. § 360(k)].  For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency, (21 CFR 807.81(b)). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at .  The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Your firm 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 FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Also, federal agencies may be advised of the issuance of 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 violations 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 devices have been corrected.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.  Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

Your firm’s response should be sent to: FDA, Denver District Office, P.O. Box 25087, (Sixth Avenue and Kipling Street, Denver Federal Center, Building 20), Lakewood, CO 80225, Attention: William H. Sherer, Compliance Officer.  If you have any questions about the contents of this letter, please contact: Mr. Sherer at (303) 236-3051.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility.  It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.  Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.



LaTonya M. Mitchell
Denver District Director