Inspections, Compliance, Enforcement, and Criminal Investigations
Refflex Technologies, Inc. 01-Feb-04
Department of Health and Human Services
Public Health Service
555 Winderley PI ., Ste. 200
RETURN RECEIPT REQUESTED
November 16, 2004
James E . Spittler, President
Reflex Technologies, Inc.
12565 Palm Road, Suite B
Miami, Florida 33181
Dear Mr. Spittler:
During an inspection of your establishment located at 12565 Palm Road, Suite B, Miami, Florida on July 30 - August 5, 2004, FDA Investigator Edward Gorney determined that your firm manufactures an external function neuromuscular stimulator (MAN Stim) and a transcutaneous electrical nerve stimulator (TENS), which 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 investigator documented significant violations from the Quality System (QS) Regulation, Title 21, Code of Federal Regulations (CFR), part 820. These violations cause the device(s) you manufacture to be adulterated within the meaning of Section 501(h) [21 U.S.C. 351(h)] of the Act.
The investigator noted the following violations of the QS regulations:
1. Each manufacturer shall establish procedures for quality audits and conduct such 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 as required by 21 CFR 820.22. Your firm has not established and implemented a procedure to conduct quality audits nor have you conducted quality audits except to review your GMP procedures (FDA 483, Item #12 & 13).
2. Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action (CAPA) including documenting all action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems as required by 21 CFR 820.100(b). Your firm has not documented any CAPA actions or activities (FDA 483, Item #1).
3. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives as required by 21 CFR 820.20(c). No management review of quality system requirements such as complaints, rework, nonconformities, and corrective and preventive action was conducted or documented (FDA 483, Item #11).
4. Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit ensuring that all complaints are processed in a uniform and timely manner as required by 21 CFR 820.198(a). Your firm failed to document and to review a complaint that was also received by the FDA and service requests are not evaluated to determine if a complaint is involved or related to the service request (FDA 483, Item #2).
5. Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50. Your firm has not documented requirements for suppliers and/or vendors (FDA 483, Item #5).
6. Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements and, define and document the responsibility for review and the authority for the disposition of nonconforming product, and establish and maintain procedures for rework as required by 21 CFR 820.90(a) & (b). Your firm failed to have procedures for controlling nonconforming devices and the rework of devices (FDA 483, Item #7, 8, & 9).
7. Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct expiration date, control number, storage instructions, handling instructions, and any additional processing instructions. The release, including the date and signature of the individual(s) performing the examination, shall be documented in the DHR as required by 21 CFR 820.120. Your firm failed to document the approval and release of device labeling, including date and signature of the examiner (FDA 483, Item #10).
8. Each manufacturer shall establish and maintain procedures for acceptance of incoming product . Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented as required by 21 CFR 820 .80(b). Your firm failed to document the acceptance of components and supplies such as solder, electronic components, and transformers. Incoming supplies were not inspected, tested, or otherwise verified that incoming components meet specified requirements (FDA 483, Item #6).
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. 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.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties. Additionally, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably related will be cleared 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.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of any steps that you are still in the process of taking to 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 assure that similar violations will not recur.
Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728.
Director, Florida District