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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Western Enterprises 13-Feb-02

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Cincinnati District Office

Central Region

6751 Steger Drive

Cincinnati, OH 45237-3097

Telephone: (513) 679-2700

FAX: (513) 679-2771

February13, 2002

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

WARNING LETTER

(CIN-WL-12039-02)

Byron Crampton, President

Western Enterprises

DBA Western, A Scott Fetzer Company

875 Bassett Road

Westlake, Ohio 44145-1142

Dear Mr. Crampton:

We are writing to you because during an inspection of your firm?s medical device manufacturing facilities located at the above address and at 1354 Lear Industrial Park, Avon, Ohio by the Food and Drug Administration (FDA) on December 7-18, 2002, our Investigator collected information that revealed serious regulatory problems involving flowmeters and oxygen regulators (including oxygen conserving regulators and vacuum suction regulators) which are manufactured and distributed by your firm.

Under the Federal Food, Drug, and Cosmetic Act (the Act), these products are considered to be medical devices. The law requires that manufacturers of medical devices conform with the requirements of the Quality System/Good Manufacturing Practice (QS/GMP) for Medical Devices Regulation as specified in Title 21, Code of Federal Regulations (CFR), Part 820.

The inspection revealed that your devices are adulterated within the meaning of section 501(h) of the Act, in that the methods used in, or the facilities or controls used for the manufacture, processing, packing, storage or distribution are not in conformance with the requirements of the QS/GMP Regulation as follows:

Failure to establish and maintain adequate procedures for receiving, review, and

evaluation of complaints by a formally designated unit ensuring all complaints are

processed in a uniform and timely manner. Complaints reviewed by Customer Service

are not always sent to the Quality Assurance (QA) department for initiation of

corrective action in a timely manner. Some complaints were not sent to the QA

department for up to 48 days after they were received. The average delay was

determined to be 14 to 15 days for the complaints reviewed by the FDA Investigator. In

addition, some complaint forms were incomplete and therefore did not always

document the underlying cause of the complaint, analysis, and the corrective action

plan.

Complaints that are not investigated by your firm have no documented reason for the lack of an investigation. For example, some complaints not adequately investigated were Complaint # M010473 dated 5/11/01 which pertained to an incident in which an

adapter shot out of the wall and scared patients and Complaint #M0111056 dated

lo/26101 which pertained to an incident in which there was a transducer & circuit board

failure. There was no further information contained in the files describing the investigation of the problems and any corrective/preventive actions taken for the

complaints. Also, complaints are not adequately reviewed and evaluated to determine

whether they represent an event reportable to the FDA under 21 CFR, Part 803, Medical Device Reporting. The MDR assessment of complaints does not consider device malfunctions that are likely to cause or contribute to a death or serious injury if

they were to recur.

Failure to establish and maintain adequate procedures for implementing corrective and

preventive action. Your firm? s Corrective and Preventive Action System includes a

Preliminary Corrective Action (PCAR) request form that is completed before an

Internal Corrective Action Request (ICAR) is initiated. The ICAR documents the final

analysis and investigation of an event and the PCAR is used to document the

preliminary assessment of the event. There are no written instructions describing the

procedure for using the PCAR forms. In addition, there is no reference to or

instructions for meeting the reporting requirements of 21 CFR Part 806, Medical

Devices; Reports of Correction And Removals.

Failure to have an adequate design control procedure. Written procedures for design

verification and validation are not adequate. Your firm? s written procedures do not

describe in detail when and how design verification and validation will be conducted.

Also, there were instances in which there was no documentation that shows that design

verification confirmed that design outputs met the design input requirements. For

example, the [redacted] test specifications were set up as a design input for the OPC Oxygen Conserving Regulator but there was no design output set up to assure that this design input was met.

Failure to establish and implement adequate record-keeping procedures. [redacted]

Device History Records were reviewed by the FDA Investigator for the HR-2600

chrome-plated brass oxygen regulators and [redacted] (20%) were determined to be incomplete. The records were for a time period of two years. Not all inspection/test results were recorded on test records.

Failure to have adequate procedures for review and disposition of nonconforming

products in that your firm does not have written procedures for reworked products.

Additionally, your firm?s devices are misbranded under Section 502(t)(2) of the Act. Specifically, your firm failed to develop and maintain written Medical Device Reporting (MDR) procedures as specified in 21 CFR 803.17. Your firm also failed to submit a Corrections and Removals Report (CAR) to FDA within 10 working days of initiating a Class II recall of your firm?s OPC-830 Oxygen Conserving Regulators as specified in 21 CFR 806.10. The regulators were recalled because the oxygen-conserving feature of the regulators failed which allowed the regulators to work in the continuous mode.

Your firm classified the event as a market withdrawal but FDA classified it as a Class II Recall. An official Corrections and Removals Report as specified in 21 CFR 806.10 was not submitted to FDA.

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the FDA 483s issued at the closeout of the FDA inspections 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 submissions for Class III devices to which the QS/GMP 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.

We received your firm?s letter of response dated January 3, 2002. In your firm?s letter of response you indicated that your firm plans to correct the deficiencies pointed out to you during the FDA inspections by February 1, 2002. However, there was no documentation submitted with the response to facilitate an evaluation of specific actions you have taken or plan to take in order to achieve permanent corrective and preventive action on your manufacturing and quality systems. In addition, we have not received any additional information from your firm indicating that all of the deficiencies have been corrected as

promised by February 1, 2002. In order for us to determine the adequacy of your firm? s response additional supporting documentation is needed.

In order to facilitate FDA in making the determination that such corrections have been made and thereby enabling FDA to withdraw its advisory to other federal agencies concerning the award of government contracts, and to resume marketing clearance for Class III devices for which a 510(k) premarket notification or Premarket Approval application (PMA) has been submitted, and Certificates to Foreign Governments for products manufactured at your medical device facilities, we are requesting that you

submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishments? manufacturing and quality assurance systems relative to the requirements of the medical device QS/GMP regulation (21 CFR, Part 820). You should also submit a copy of the consultant?s report, and certification by your establishments? Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant? s report and that your establishment has

initiated or completed all corrections called for in the report. The attached guidance may be helpful in selecting an appropriate consultant.

The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:

  • Initial certifications by consultant and establishment -August 12, 2002.
  • Subsequent certifications-August 10, 2003 and August 9, 2003.

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 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.

Your response to this Warning Letter should be sent to Evelyn D. Forney, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237-3097.

Sincerely,

Henry L. Fielden

District Director

Cincinnati District