Inspections, Compliance, Enforcement, and Criminal Investigations
Electro Medical, Inc. 07-Sep-05
Department of Health and Human Services
Public Health Service
September 7, 2005
RETURNED RECEIPT REQUESTED
Mr. James H. Shores, President
Electro Medical, Inc.
9736 E. 55th Place
Tulsa, OK 74146-6401
Dear Mr. Shores:
During an inspection of your establishment located in Tulsa, Oklahoma; on June 28, 2005 through July 22, 2005, a United States Food and Drug Administration (FDA) investigator determined that your firm manufactures the Stim Flex Model 400 and Model 4OOA Transcutaneous Electrical Nerve Stimulators (TENS) for pain relief. These products are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). 21 U.S.C. 321(h).
The above-stated inspection revealed that your devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C. 351(h)) because the methods used in, or the facilities or controls used for the manufacturing, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Your devices are also misbranded within the meaning of Section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), because your firm failed to establish written medical device reporting (MDR) procedures, as required by Section 519 of the Act, 21 U.S.C. 360i, and the MDR Regulation, 21 C.F.R. Part 803.
At the close of the above stated inspection, your firm was issued a List of Inspectional Observations, Form FDA-483, which identified a number of significant QS Regulation violations including, but not limited to, those described below:
Quality System Regulation
1. Your firm's management with executive responsibility failed to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization, as required by 21 CFR 820.20 [FDA-483 Items 1 through 31].
2. Your firm failed to establish and maintain adequate complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to ensure that all the requirements of 21 CFR 820.198(a) through (e) are met [FDA-483 Items 7, 8, 9, 11]. For example:
a) Between January 2002 and the conclusion of our inspection, your firm received 65 complaints/repair requests. Your firm did not conduct formal investigations of these complaints or justify and document why investigations were not necessary. 37 of them did not document what type of repair or corrective action was taken, and many other complaints had incomplete documentation to show what specific components were found defective and subsequently replaced. 32 of them did not document the date your firm received the complaints, and (14) of them did not document the year your firm received the complaints. Only the month and date were recorded. Finally, 30 of them had incomplete addresses and no phone numbers of the complainants.
b) Your firm has several versions of a complaint handling procedure, but none of them have revision numbers, effective dates, and signatures indicating approval. As such, it is not possible to determine which version of the complaint handling procedure was approved for use.
3. Your firm failed to establish and implement adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d), and to include maintaining acceptance records, as required by 21 CFR 820.80(e) [FDA-483 Items 1, 2, 3, 5, 23]. For example:
a) Of the [redacted] devices manufactured from January 1, 2003 to June 3, 2005, (106) devices did not have an Instrument Control Form documenting the acceptance testing and authorization for distribution for each device. Of the (26) Instrument Control Forms that were completed, (8) of them were dated after the devices had been distributed.
b) The undated finished device acceptance procedure entitled "History" does not describe who (Electro Medical and/or the contract manufacturer) is responsible for conducting the [redacted] burn-in test to detect premature component failures. Both your firm and the contract manufacturer failed to follow this procedure in that the devices were actually tested for [redacted] rather than [redacted] [redacted].
c) Your firm has no written acceptance procedures for the inspection or testing of the mono-polar and bi-polar electrodes.
4. Your firm failed to establish and maintain procedures for acceptance or rejection of incoming product, including documentation of the results of acceptance or rejection, as required by 21 CFR 820.80(b) [FDA-483 Items 4 and 6]. For example, your firm does not have written procedures for the inspection of incoming products, such as the incoming Stim Flex 400 and 400A devices from the contract manufacturer, electronic components, and raw materials. You verbally indicated to our investigator that a number of the incoming printed circuit boards (PCBs) were bridged (e.g. short circuit) and were later rejected and returned to the supplier. Your firm does not document who conducted the inspection, the reason for the rejection, and how many PCBs were accepted or rejected.
5. Your firm failed to establish and maintain documented instructions, standard operating procedures (SOP's), and methods that define and control the manner of production, as required by 21 CFR 820.70(a)(1) [FDA-483 Item 21]. For example, your firm does not have written procedures for the assembly of the circuits of the Stim Flex Model 400 and 400A and the mono-polar and bi-polar electrodes.
6. Your firm failed to establish and maintain procedures for changes to a specification, method, process, or procedure, including validation or verification of such changes, as required by 21 CFR 820.70(b) [FDA-483 Items 14, 15, and 16]. For example, your firm has made several changes to the device, assembly of the Stim Flex Model 400 (e.g. a change in the [redacted] in the location of the [redacted] and associated). These device assembly changes were not documented and verified to determine if there was any adverse effect to the functionality of the device. Additionally, your firm has not established written procedures to describe how changes to specifications or production processes (a) are to be reviewed, validated or verified, approved, and documented, and (b) are to be communicated to the contract manufacturer.
7. Your firm failed to establish and maintain procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i) [FDA-483 Item 20]. For example, your firm is in the process of making a design change to prevent the device from leaking currents under certain circumstances without establishing a design change procedure.
8. Your firm failed to establish and maintain data that clearly describes or references the specified requirements, including quality requirements, for purchased or otherwise received product and services that must be met by the suppliers, contractors, and consultants, as required by 21 CFR 820.50(a) and (b) [FDA-483 Items 17, 18, and 19]. For example, your firm has not (a) established and documented specific quality requirements and specifications for the printed circuit boards and printed labels placed on the device case; and (b) defined the method and frequency of evaluation or audit of the suppliers and the contract manufacturer.
9. Your firm failed to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184 [FDA-483 Item 13]. For example, your firm does not maintain device history records, including the dates and quantity of manufacture, the quantity released for distribution, and the results of acceptance activities, for the mono-polar and bi-polar electrodes.
10. Your firm failed to maintain device master records (DMR's) to include or refer to the location of device specifications, production process specifications, quality assurance procedures, and packaging and labeling specifications, and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181 [FDA-483 Items 21, 22, and 23]. For example:
a) Your firm was able to locate some drawings of the circuit boards, but these drawings were not reviewed and approved and did not contain all the changes found on the drawings at the contract manufacturer.
b) Your firm's handwritten packaging procedure and Instrument Check Out procedure have not been reviewed and approved.
11. Your firm failed to establish and maintain procedures for quality audits and conduct such audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22 [FDA-483 Items 28 and 29]. For example, your firm has never conducted any internal audits of its quality system and has no written audit procedures defining (a) how and what specific areas of your firm's quality system are to be audited, and (b) the audit interval.
Medical Device Reporting Regulation
Additionally, the above-stated inspection 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 or refused to furnish any material or information required by or under section 519, 21 U.S.C. 360i, and 21 CFR Part 803-Medical Device Reporting (MDR) regulation, respecting the device. For example:
1. Failure to develop, maintain, and implement written MDR procedures that address the review of complaint information to determine the need to report information as an MDR, as required by 21 CFR 803.17 [FDA 483 Item 30]. Your firm does not have any written MDR procedures.
Responding to This Letter
Due to the nature and quantity of the inspectional observations, we suggest your firm use a qualified quality system consultant to help identify any gaps in your firm's quality system in order to establish and implement complete and comprehensive quality system procedures that will (a) correct the inspectional observations issued at the conclusion of our inspection on July 22, 2005, and the items identified in this warning letter, and (b) prevent a recurrence of CGMP violations.
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 Form FDA- 483 may be symptomatic of other serious underlying problems in your firm's manufacturing and quality assurance systems.
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 applications for premarket approval to which the Quality System regulation deficiencies are reasonably related will be approved 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.
You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken, or will take to identify and correct the noted violations, including (1) the timeframes within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to ensure that similar violations will not recur.
Your response should be sent to Thao Ta, Compliance Officer, DAL-DO, Food and Drug Administration, HFR-SW140, 4040 N Central Expressway, Suite 300, Dallas, TX 75240. If you have any questions about the contents of this letter, please contact Mr. Ta at 214-253-5217.
Michael A. Chappell
Dallas District Director