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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hearing Aid Express 22-Feb-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

Dallas District

4040 North Central Expressway

Dallas, Texas 75204-3145

February 22, 2002

Ref: 2002-DAL-W-11

WARNING LETTER

CERTIFIED MAIL

RETURNED RECEIPT REQUESTED

Mr. Mark A. Brumback, President

Hearing Aid Express

11888 Marsh Lane, Suite # 111

Dallas, Texas 75234

Dear Mr. Brumback:

On December 18 through 21, 2001, our FDA investigator conducted an establishment inspection of your device manufacturing facility located in Dallas, Texas. Our investigator determined that your firm manufactures several models of Air Conduction Hearing Aid devices, such as the Full Shell Air Conduction Hearing Aid, Canal Air Conduction Hearing Aid, Push Pull Air Conduction Hearing Aid, and Ultra Mini Air Conduction Hearing Aid. These products are medical devices as defined in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

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 their manufacturing,

packing, storage, or installation are not in conformance with the Current Good

Manufacturing Practice (CGMP) requirements of the Quality System Regulations,

as specified in Title 21, Code of Federal Resulation (CFR), Part 820. Significant

GMP deviations include, but are not limited to, the following:

1. Failure to conduct management reviews at defined intervals [21 CFR

820.20(c)] [FDA-483 Item 2].

2. Failure to conduct internal quality audits at defined intervals according to your

firm?s written procedures [21 CFR 820.221 [FDA-483 Item 3].

3. Failure to document employee training and failure to establish procedures for

identifying employee training needs [21 CFR 820.25(b)] [FDA-483 Items 4

and 5].

4. Failure to analyze processes, work operations, concessions, quality audit

reports, quality records, service records, complaints, returned product, and

other sources of quality data to identify and document existing and potential

causes of non-conforming product, or other quality problems [21 CFR

820.100(a)(1)]. For example, from January, 2001 through June, 2001, your

firm received 146 defective hearing aids for repair but did not trend the repair

data for unfavorable trends and for determining if a quality or product problem

existed [FDA-483 Item 6].

5. Failure to establish complete corrective and prevent action procedures that

address all requirements in 21 CFR 820.100(a)(l) through (b) [FDA-483 Item

7].

6. Failure to establish procedures for the identification, documentation, evaluation, segregation, and disposition of nonconforming product [21 CFR 820.90]. For example:

  1. Procedures for rework of non-confomring product have not been established (FDA483 Item 12]; and
  2. Rework activities performed have not been documented in the device

history records [FDA483 Item 13]; and

(c) There is no documentation of the disposition of nonconforming product.

For example, hearing aid shells that failed to meet fabrication specifications were scrapped, and new shells were fabricated, and this was not documented [FDA483 Item 14].

7. Failure to investigate and document defective hearing aids returned to your

firm for repair for determining possible root causes and product quality trends

[21 CFR 820.198 (c)] [FDA483 Item 8].

8. Failure to conduct and document testing verification or validation of

manufacturing process changes [21 CFR 820.75(c)]. For example, your firm

could not provide documentation of any tests and/or evaluation conducted to

ensure that the change in the fabrication process from a [redacted] curing process

to a [redacted] curing process does not affect the quality of the hearing aid shell

[FDA-483 Item 11].

9. Failure to evaluate suppliers on the basis of their ability to meet specified

requirements, including quality requirements [21 CFR 820.50(a)]. For

example, your firm has evaluated and approved current suppliers based on

their past performance but has not documented such evaluations [FDA-483

Item 18].

Your firm verbally promised our investigator that it would correct all observations

with time frames ranging from 30 days to 90 days, but has not submitted a

written response confirming your promise and outlining specific steps your firm

has taken or will take to correct the above GMP deficiencies.

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 FDA-483

issued at the close of the inspection 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. If the causes are determined to be systems problems, you

must promptly initiate permanent corrective actions.

Until these violations are corrected, and FDA has documentation to establish that such corrections have been made, federal agencies will be advised of the issuance of this Warning Letter so that they may take this information into account when considering the award of contracts.

You should take prompt action to correct these violations. Failure to promptly

correct these violations 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 provide this office in writing within 15 working days of receipt of this letter

a report of the specific steps you have taken, or will take to identify and correct

any underlying systems problems necessary to assure that similar violations will

not recur. If corrective action cannot be completed within 15 working days, state

the reason for the delay and the time frame within which the corrections will be

completed. Your reply should be directed to Thao Ta, Compliance Officer, at the

above letterhead address.

Sincerely,

Michael A. Chappell

Dallas District Director