Inspections, Compliance, Enforcement, and Criminal Investigations
Electrologic of America, Inc. 09-May-05
Department of Health and Human Services
Public Health Service
Cincinnati District Office
May 9, 2005
VIA FEDERAL EXPRESS
Mr. William L. Phillips
Electrologic of America, Inc.
2790 Indian Ripple Road
Dayton, OH 45440-3638
Dear Mr. Phillips:
An inspection of your medical device manufacturing firm located in Dayton, OH conducted by our investigators on March 15-18 and 22, 2005, revealed that your firm manufactures electrical muscle stimulation stationary bicycles. These are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 321(h)]. They are Class II devices as defined in Title 21, Code of Federal Regulations (CFR), section 890.5850.
Your devices are 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 manufacturing, packing, storage, or installation are not in conformance with the Quality System Regulation (QSR), as specified in 21 CFR Part 820.
The deviations from the QSR include, but are not limited to, the following:
1. Failure to establish adequate management controls to ensure that an effective quality system has been established and maintained. [21 CFR 820.20] For example:
Quality system procedures have not been established. [21 CFR 820.20(e)] For example, there are no written corrective and preventive action procedures, design control procedures, medical device reporting procedures, and training procedures.
2. Failure to conduct quality audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. [21 CFR 820.22]
3. Failure to develop training procedures and to adequately train personnel to perform their assigned responsibilities. [21 CFR 820.25(b)] Specifically, no quality or manufacturing employees have been trained on the quality system regulations.
Production and Process Controls
4. Failure to have procedures for addressing the identification, documentation, evaluation, segregation, disposition, and investigation of nonconforming products; and failure to document nonconformances. [21 CFR 820.90(a)] Specifically, on 7/2/04 the StimMaster Galaxy device S/N E25h2125 failed mechanical assembly verification testing and a belt was replaced . The segregation and disposition of the belt; and an investigation of why the belt failed was not performed and documented.
5. Failure to document all finished device acceptance activities. [21 CFR 820.80(d)] Specifically, 5 of the 26 device history records the FDA investigators reviewed did not have all the testing required by the PRODUCTION/SERVICE ACCEPTANCE TEST PROCEDURE completed.
6. Failure to have written procedures for rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, in the device history record. [21 CFR 820.90(b)(2)] Specifically, on 7/2/04 the StimMaster Galaxy device, S/N E25h2125 was reworked due to failure during the Mechanical Assembly Verification . There are no procedures requiring documenting the rework and what testing is required.
7. Failure to perform acceptance activities, including inspections, tests, and other verification activities, for incoming components [21 CFR 820.80b]
8. Failure to include, or refer to the location of the primary identification label and labeling used for each production unit of the StimMaster bicycles in the device history records. [21 CFR 820.184]
Corrective and Preventive Actions
9. Failure to establish procedures for implementing corrective and preventive actions; and failure to document corrective and preventive activities, including analysis of quality data sources, investigations of causes of nonconformances, and implementation of corrective and preventive actions. [21 CFR 820.100]
10. Failure to establish formally designated unit and a complaint handling procedure that ensures that all complaints are processed in a uniform and timely manner; oral complaints are documented upon receipt; and all complaints are evaluated, investigated, and appropriate corrective actions are taken. [21 CFR 820.198] Specifically, your CUSTOMER SERVICE procedure does not assure that all the above requirements are performed; and as you stated to the FDA investigator, this procedure is only used for device parts that are returned for repair, not for oral complaints.
11 . Failure to verify, validate and create a design history file when design changes were made to the StimMaster electrical muscle stimulation stationary bicycle [21 CFR 820.30(i) and (j)] . Engineering Change Notice, dated 11/1/02, states that four inches were removed from the front of the seat, a keypad was added and the buttons were removed, the riding angles were adjusted, and the software was upgraded. There is no verification and validation testing, including software validation, documented for these changes; and a design history file which includes inputs, outputs, verification, validation, design reviews, and design transfer documents was not created.
12. Failure to establish design control procedures to include procedures for design inputs, design outputs, design verifications, design validation, design reviews, design transfer, and design changes.[21 CFR 820 .30(a)]
The inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act [21 U.S.C. 352(t)(2)], in that your firm failed to develop written Medical Device Reporting procedures as required by 21 CFR 803.17.
You should know that these are serious violations of the law. 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. Possible actions include, but are not limited to, seizure, injunction, and/or civil penalties.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. As president of Electrologic of America Inc., it is your responsibility to assure adherence to each requirement of the Act and regulations. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be system problems, you must promptly initiate permanent corrective actions.
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 these deficiencies . In addition, please submit any additional documentation to show the corrections initiated in conformance with the requirements of the Quality System Regulation. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed.
Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts. Additionally, no requests for Certifications to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
Your written response to this Warning Letter should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679- 2700, extension 167, or you may forward a facsimile to her at (513) 679-2773.
Carol A. Heppe