Inspections, Compliance, Enforcement, and Criminal Investigations
The Electrode Store, Inc. 23-Nov-05
Department of Health and Human Services
Public Health Service
November 23, 2005
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-16
Timothy S. Cooke, President
The Electrode Store, Inc.
159 West Mason Avenue
Buckley, WA 98321-9536
Dear Mr. Cooke:
On October 3-6, 2005, the U.S. Food and Drug Administration (FDA) conducted an inspection of your firm, located at 159 West Mason Avenue, Buckley, Washington. FDA has determined your firm manufactures electroencephalograph (EEG) and electromyography (EMG) surface and needle electrodes. These products are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). You may find the Act and associated regulations through links at FDA's home page at www.fda.gov.
This inspection revealed the devices are adulterated under section 501(h) of the Act, as the methods used in, or the facilities or controls used for, their 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), Part 820.
Significant deviations found during the inspection include, but are not limited to, the following:
1. Procedures were not established and maintained for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75(b). For example:
a. You were unable to produce documentation to verify that dosimetry of routine production loads to demonstrate the degree of process control required for dosimetric release of sterilized products has been performed as required in the June 2004 validation report of the EMG Needle Electrode prepared by [redacted]
b. You were unable to produce documentation to verify that dose audits have been periodically performed to substantiate the continued validity of the [redacted]kGy dose as a [redacted] Sterility Assurance Level (SAL) dose as required by the June 2004 validation report.
2. Processes for which the results cannot be fully verified by subsequent inspection and test were not validated with a high degree of assurance according to established procedures, as required by 21 CFR 820.75(a). For example:
a. The Radiation Services Agreement with [redacted] dated August 31, 1999, and currently effective, lists a minimum reference dose of [redacted]kGy for electrodes that were validated at not less than a [redacted] kGy dose.
b. There is no documentation of verification of product performance following sterilization at a maximum allowed dose of [redacted]kGy allowed for on the Notice of Intended Delivery Medical Products form shipped with product to the contract sterilizer.
3. Acceptance procedures were not established to ensure that specified requirements for in-process product are met, as required by 21 CFR 820.80(c). For example:
a. The pull tests in the Work Instructions for the DTM-Series and the PRO-Series Monopolar Disposable Needles to ensure adequate assembly are not measurable or repeatable as to the exact amount of pulling to be considered acceptable. The instructions require pulling "gently but firmly" but not with "all your strength".
b. There is no documented data to demonstrate that the in-process electrical testing of coated needles will ensure that specified requirements are met and that this testing can effectively verify the adequacy of the needle coating process.
4. Procedures for identifying valid statistical techniques were not established and maintained for establishing, controlling, and verifying the acceptability of process capability and product characteristics, as required by 21 CFR 820.250(a). For example, the sampling plan for the pull tests in the Work Instructions for the DTM-Series and the PRO-Series Monopolar Disposable Needles to ensure adequate assembly state only to "Randomly check . . ." the needle and wire assembly.
5. The corrective and preventative action implemented for Complaint 2004-005 and CAPA 2004-013 involving the separating of needle electrodes at the hub was not vcrificd or validated to ensure that such action is effective and does not adversely affect the finished product, as required by 21 CFR 820.100(a)(4). For instance, you did not verify the acceptable performance of the new hand operated crimping tool implemented into production as part of the corrective action for the CAPA.
6. The record of a complaint investigation did not include the results of the investigation, as required by 21 CFR 820.198(e)(6). For instance, the results of the investigation into Complaint 2005-008 does not include any information obtained from any direct contact with the user or the results of the analysis you initiated at the plating vendor.
7. The Corrective and Preventive Action procedures do not include analyzing other sources of quality data to include concessions, quality audit reports, quality records, service records, returned product, to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a)(1). Your procedures include only analyzing complaint data.
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 regulations. The specific violations noted in this letter and in the Form 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. 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 QSR deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates for Products for Export 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 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.