Inspections, Compliance, Enforcement, and Criminal Investigations
General Hearing Instruments Inc 9/18/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
September 18, 2013
WARNING LETTER NO. 2013-NOL-18
UNITED PARCEL SERVICE
Delivery Signature Requested
Roger P. Juneau, President
General Hearing Instruments, Inc.
175 Brookhollow Esplanade
Harahan, Louisiana 70123-5101
Dear Mr. Juneau:
During an inspection of your firm, located at 175 Brookhollow Esplanade, Harahan, Louisiana, on August 12-15, 2013, investigators from the United States Food and Drug Administration (FDA) determined your firm manufactures ready-wear-air conduction hearing aids. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 United States Code (USC) 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC Section 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). We received your response letter, with enclosures, dated September 5, 2013, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483), issued to you on August 15, 2013. We received your supplemental response, dated September 6, 2013, which noted your consult with Master Controls to review, counsel, and guide you in properly implementing the corrective actions. We address the responses below, in relation to each of the noted violations. The violations include, but are not limited to, the following:
1. Failure to adequately establish and maintain procedures for implementing corrective and preventive action (CAPA) including requirements for analyzing sources of quality data, investigating the cause of nonconformities from sources other than product returns, requirements for identifying required actions, or requirements for verifying the effectiveness of actions, as required by 21 CFR 820.100(a). For example, your firm failed to document the evaluation and effectiveness of a change in the component material and bonding chemicals resulting from a CAPA regarding a component of the device detaching inside the ear canal.
We have reviewed your CAPA procedure and note it addresses our concerns on the citation noted above; however, the procedure is not signed and dated as approved and implemented.
2. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, your complaint procedure does not designate a specific unit handling complaints. In addition, you document complaints in an electronic database; however, this is not addressed in your complaint procedure.
You explain the complaint procedure is integrated into the CAPA procedure. The CAPA procedure does not adequately explain the specific responsibilities and steps your firm will take to record, evaluate, and address the complaint.
3. Failure to adequately maintain your device master file, as required by 21 CFR 820.181. Specifically, you failed to include software specifications, quality assurance specifications, and packaging/labeling specifications for your hearing devices.
We agree with your proposed corrective action noted in item number 3.
We agree with your proposed corrective action noted in item number 3.
4. Failure to establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). Specifically, you failed to establish procedures addressing the identification, control, review, and disposition of nonconforming products or identifying individuals authorized to make final dispositions.
You explain the procedure for handling nonconforming product is integrated into the CAPA procedure. The CAPA procedure does not adequately explain the specific responsibilities and steps your firm will take to record, evaluate, and address the nonconforming products.
5. Failure to establish procedures for conducting quality audits, as required by 21 CFR 820.22. Specifically, you failed to conduct quality audits in accordance with established procedures.
6. Failure to establish procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your procedures for inventory control do not identify supplier requirements, contain instructions on how suppliers will be evaluated, or identify the type and extent of control to be used during supplier evaluations.
7. Failure to establish design control procedures, as required by 21 CFR 820.30(a). Specifically, you failed to establish procedures to ensure specific design requirements will be met, the establishment of design inputs or outputs, requirements for formal document design reviews, requirements for verification and validation of the design, design transfer, or control of design changes.
8. You failed to adequately develop, maintain, and implement medical device reporting Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. Specifically, your procedure fails to provide the following:
- A timely and effective identification, communication, and evaluation of potentially reportable events to the FDA;
- Does not establish a standardized review process including instructions for conducting investigations and evaluations;
- Contains conflicting submission timeframe requirements;
- Does not identify documentation and recordkeeping requirements for evaluations of potentially reportable events; and,
- Does not define key terms such as “serious injury” or “caused or contributed.”
You explain the procedure for handling MDR is integrated into the CAPA procedure. The CAPA procedure does not adequately explain the specific responsibilities and steps your firm will take to record, evaluate, and address complaints for reporting MDR’s to FDA.
You should take prompt action to correct the violations addressed in this letter for which you have not already provided an adequate response. 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/or civil money penalties. Also, federal agencies are advised of the issuance of all warning letters about devices so 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 deviations 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations for which you have not already provided an adequate response, including an explanation of how you plan to prevent these violations, or similar violations, from recurring. Include documentation of the corrective action you have taken, such as your revised procedures. 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 Mr. Mark W. Rivero, Compliance Officer at the above address. If you have any questions about the content of this letter please contact Mr. Rivero at (504) 832-1290, extension 1103.
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 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.
Patricia K. Schafer
New Orleans District