Inspections, Compliance, Enforcement, and Criminal Investigations
Superior Rehab Technology, Inc. 27-Jul-05
Department of Health and Human Services
Public Health Service
July 27, 2005
RETURNED RECEIPT REQUESTED
Mr. Terry L. Young, Vice President
Superior Rehab Technology, Inc.
27481 Smithson Valley Rd.
San Antonio, TX 78249
Dear Mr. Young:
Between May 9 and 25, 2005, the United States Food and Drug Administration (FDA) conducted an inspection of Superior Rehab Technology, Inc., at the above-referenced address. Your firm manufactures and distributes the Superior 2000TM, 3000TM, and 4000TM Electronic Muscle Stimulators (EMS). These prescription medical devices are intended for (a) the immediate post-surgical stimulation of calf muscle to prevent venous thrombosis, (b) the prevention or retardation of disuse atrophy, (c) muscle education, (d) maintaining or increasing range of motion, (e) increasing blood circulation, and (f) relaxation of muscle spasms. Therefore, these products 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).
The FDA inspection revealed that your devices are adulterated and misbranded within the meaning of the Act. 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 (C.F.R.), Part 820. Your devices are 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 inspection, FDA issued you a List of Inspectional Observations, Form FDA-483, which identified significant violations of the QS Regulation, which include, but are not limited to, the following:
1. Failure of management with executive responsibility 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 C.F.R. 820.20 [FDA-483 Item 1]. For example, your firm has not established and maintained: (a) a quality policy or objectives and a quality plan for the Manufactured electronic muscle stimulators; (b) procedures for conducting and documenting management reviews and quality audits; and (c) procedures for handling complaints.
2. Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 C.F.R. 820.198(a) [FDA-483 Item 4]. For example, your firm has not maintained complaint files for your medical devices. You recorded Incoming customer calls concerning defective electronic components in the Device Encounter Forms, but these forms were not evaluated as product complaints. The Device Encounter Forms also did not document (a) the name, address, and phone number of the complainant (caller), (b) why an investigation is not necessary, (c) patient involvement, (d) any corrective action taken, and (e) any reply to the complainant.
You stated to our investigator that these incoming calls were considered service related calls, rather than product complaints. FDA disagrees. Your firm has not established a complaint handling procedure to receive, review, investigate all complaints, and it has not defined whether servicing is a specified requirement and documented all specific servicing requirements for your EMS devices (see 21 C.F.R. 820.200) to determine whether incoming customer calls are scheduled service calls or product complaints. Furthermore, the Owner's Instruction Manuals for three of the EMS models you provided to our investigator do not document any routine or scheduled servicing requirements required for these electronic devices. Finally, internal electronic components of electronic devices (e.g., LCD display, resistors, capacitors, diodes, power amplifiers, transistors, and microchips) are not components that require routine or scheduled servicing. Their premature failures or trend of failures, and the risk of their failures to patients, must be investigated to determine the possible root cause.
3. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 C.F.R. 820.30(a) [FDA-483 Item 7]. For example, your firm, as a specification developer, has not established design change procedures to control, validate or verify, and approve design changes before their implementation. Furthermore, your firm has not established design transfer procedures to ensure that the original design specifications or design change specifications are correctly translated into production specifications used by the contract manufacturer.
4. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 C.F.R. 820.50 [FDA-483 Item 8]. For example, your firm has not established written specified requirements, including quality requirements, that must be met by your contract manufacturer (purchasing data).
You stated to our investigator that you had not followed the current written manufacturing agreement with the contract manufacturer but had on-going verbal agreement with them to initiate design changes and manufacture the EMS devices that would meet your firm's quality and specific design requirements. Your verbal agreement with the contract manufacturer was not documented.
5. Failure to establish and maintain procedures for acceptance or rejection of incoming product and to include documenting the results of acceptance or rejection, as required by 21 C.F.R. 820.80(b) [FDA-483 Item 9]. For example, your firm has not: (a) established acceptance procedures for the inspection, testing, or verification of incoming products to ensure that they meet your firm's specified requirements; and (b) documented the results of acceptance or rejection.
You stated to our investigator that you ran a [redacted] test of the EMS devices that included [redacted] and attaching the device electrodes to yourself. You failed to document these test results and to justify that testing the devices on yourself is a valid scientific test.
6 . Failure to establish and maintain procedures for implementing corrective and preventive actions and documenting these actions, as required 21 C.F.R. 820.100(a) and (b) [FDA-483 Item 6]. For example, your firm has no procedures for analyzing processes, work quality records, service records, complaints, returned products, and other sources of quality data to identify existing potential causes of nonconforming product and to investigate the causes of nonconformities relating to the product, processes, and the quality system.
7. Failure 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 C.F.R. 820.184 [FDA-483 Item10}. For example, your firm has not established procedures defining the specific types of information and acceptance records needed to be included in the device history records.
8. Failure to establish and maintain procedures to control labeling activities and to include printing legible labels, labeling inspection, labeling storage, and labeling operations, as required by 21 C.F.R. 820.120 [FDA-483 Item 12]. For example, your firm has not established labeling procedures to address the content of labels, how labels are generated, where labels are affixed to the EMS devices and/or their packaging, and how labels and labeling are inspected.
9. Failure to maintain device master records (DMR's) to include or refer to the location of device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and to ensure that each DMR is prepared and approved in accordance with 21 C.F.R. 820.40, as required by 21 C.F.R. 820.181 [FDA-483 Item 11). Although your firm provided a list of the contract manufacturer's production procedures and some electronic circuit diagrams of the EMS devices for review by our investigator, your firm's device master record is incomplete in that your firm has not established procedures for all quality assurance and labeling activities and documented specific test equipment to be used at your firm.
10. Failure 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 C.F.R. 820.22 [FDA-483 Item 2]. For example, your firm has not established procedures for internal audit of your firm's quality system and external audit of the contract manufacturer's quality system. Moreover, your firm has not conducted such audits. Your firm verbally stated to our investigator that your firm had visited the contract manufacturer several times during the time of manufacturing, but that your firm could not remember the actual dates of visit and has not maintained your audit results of their manufacturing operations.
The Form FDA-483 also identified the following violations of the MDR regulation:
1. Failure to develop, maintain, and implement written MDR procedures, as required by 21 C.F.R. 803.17 [FDA-483 Item 5]. Your firm has not established any written MDR procedures for the timely and effective identification, communication, and evaluation of events that may be subject to the medical device reporting requirements.
Responding to This Letter
This fetter 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 issued at the close of the inspection may be symptomatic of other 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 must also 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 approval applications for Class III devices 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 the 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 time frames 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 reply should be directed to Thao Ta, Compliance Officer, at the address indicated on the above letterhead.
Michael A. Chappelli
Dallas District Director