Department of Health and Human Services
Public Health Service
555 Winderley Pl #200
December 2, 2005
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Craig H. Turtzo, President
Restorative Products, Inc.
13560 Wright Cir
Tampa, FL 33626
Ref. No. FLA-06-08
Dear Mr Turtzo:
During an inspection of your establishment located in Tampa, FL, on June 28 — July 1, 2005, an FDA Investigator determined that your establishment is a manufacturer and distributor of an infrared lamp device (Class II). These products are devices, as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(h)]. The devices emit energy in the infrared spectrum to provide topical heating for the treatment of minor muscle and joint pain.
The investigator documented violations of the Act causing the devices to be adulterated within the meaning of sections 501(f)(1)(B) [21 USC 351(f)(1)(B)] and 501(h) [21 USC 351(h)] and misbranded within the meaning of section 502(o) [21 USC 352(o)] and 502(t)(2) [21 USC 352(t)(2)] of the Act.
Your device received clearance as an electric heating pad on March 30, 1994 (K931261). On October 19, 2001, FDA corrected this clearance and stated that the device "should have been classified as an infrared lamp rather than an electric heating pad." The clearance letter stated that you could "continue marketing your device as described in your Section 510(k) premarket notification." This 510(k) submission described the device as intended for relief of minor muscle and joint pain and improvement of superficial circulation.
Our inspection determined that your product labeling and internet website promote the Anodyne Therapy System for use in the treatment of wounds and ulcers, loss of protective sensation, gait and balance impairment, and other Diabetic Peripheral Neuropathy conditions, as well as conditions associated with Non-diabetic Neuropathies. Your company is also promoting the Anodyne Therapy System for the treatment of conditions including, but not limited to, soft tissue injuries, Carpal Tunnel Syndrome (CTS), and lymphedema. According to our records, however, you do not have marketing clearance from FDA to distribute into interstate commerce the Anodyne Therapy System for these uses.
The promotion of the Anodyne Therapy System for these uses indicates a major modification in the intended use of the device and requires a new premarket submission. 21 CFR 807.81(a)(3)(ii). Because you do not have marketing clearance from the FDA for these new intended uses, marketing the Anodyne Therapy System with these claims is a violation of the law. Your promotion and introduction into interstate commerce of this device for uncleared indications renders it adulterated under section 501(f)(1)(B) of the Act, for failure to obtain FDA premarket approval, and misbranded under section 502(o) of the Act, for failure to notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act. For a product requiring premarket approval before marketing, the notification required by section 510(k) of the act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency. 21 CFR 807.81(b).
Quality System Regulation
The above-stated inspection revealed that these devices are adulterated under section 501(h) of the Act [21 USC 351(h)], in that the methods used in, or the facilities or controls used for, the 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 regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations observed include, but are not limited to, the following:
- Your firm failed to establish and maintain procedures for implementing corrective and preventive action. In particular, you do not have a procedure to identify the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems as required by 21 CFR 820.100(a)(3). Your firm has received 29 reports of burns (thermals) from users of the Anodyne Therapy System from August 2004 to April 2005 and failed to adequately investigate all of the reports and to take effective preventive action (FDA 483, Item #1).
- Your firm failed to analyze processes, quality records, service records, and other sources of quality data to identify existing and potential causes of non-conforming product, or other quality problems as required by 21 CFR 820.100(a)(1). In particular, your firm failed to analyze in-process rejects and to analyze burn report trends. Your firm only analyzes complaints when the actual device is returned to your facility (FDA 483, Item #10).
- Your firm's corrective and preventive action (CAPA) procedure does not include a requirement that each CAPA be verified or validated to ensure that such action is effective and does not adversely affect the finished device (FDA 483, Item #9). 21 CFR 820.100(a)(4).
- Where the results of a process cannot be fully verified by subsequent inspection and test, the process must be validated with a high degree of assurance and approved according to established procedures as required by 21 CFR 820.75(a). Your firm failed:
- to document the validation study of the new Pick & Place and Wave Soldering Equipment which are used to produce printed circuit boards for the Anodyne Therapy device, and
- to complete adequate validation of the new Inserter device used to produce Array boards as follows:
- Lacks documentation of installation and operation qualification of equipment,
- Fails to establish a high degree of assurance that the device meets specifications and can be manufactured consistently in that only 4 Array boards were included in Performance Qualification; and
- Failed to document settings used for the Performance Qualification (FDA 483, Item #2). 21 CFR 820.75(b)(2).
- Your firm failed to review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications as required by 21 CFR 820.198(c). Your firm failed to obtain adequate information during the investigation of 7 reports related to patients receiving burns as a result of using the Anodyne Therapy device. During investigation of six reports, your firm failed to determine if the user who sustained the injury received medical treatment, the severity of the burns received, and whether the patient was diabetic. This is a repeat of an observation made during the previous inspection dated July 8, 2003. During the investigation of Complaint #1457 dated 10/29/2004, your firm documented that arrays were repaired, but not what was needed to repair the arrays. During investigation of Complaints #1814 and #1952 dated 1/27/2005, your firm documented that defect(s) were found but there is no documentation of the exact nature of the defect(s) (FDA 483, Item #6).
- Your firm failed to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72(a). In particular, your firm did not establish and maintain procedures for calibrating temperature and speed controls on wave soldering equipment and an oven. (FDA 483, Item #7).
- Your firm failed to establish and maintain procedures to control environmental conditions that could reasonably be expected to have an adverse effect on product quality as required by 21 CFR 820.70(c). Your firm's soldering work instructions require that sensitive components and circuit boards, when not being worked on, must be enclosed in shielding bags or boxes. The investigator observed a minimum of 10 antistatic bags containing sensitive components and p.c. boards in open bags in the storage area (FDA 483, Item #8).
- Your firm failed to maintain complete design history records (DHRs) as required by 21 CFR 820.184(d). Your DHR fails to include complete acceptance records that demonstrate the device is manufactured in accordance with the device master record (DMR). Your firm fails to document the visual inspection by magnification of p.c. boards after wave soldering (FDA 483, Item #3).
- A design history file (DHF) must contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan as required by 21 CFR 820.30(j). Your firm's DHF fails to demonstrate that the design was developed following the approved design plan and the design control requirements, e.g., (a) your firm lacks documentation of design verification, design review, design validation, risk analysis, approval by a designated official, and the effective date of a design change made to wiring of arrays for the Anodyne Therapy device which was first released on 5/26/2005 (FDA 483, Item #4).
- Your firm failed to designate a responsible individual(s) to review for adequacy and approve prior to issuance all documents established to meet the QSR requirements. The approval, including the date and signature of the individual(s) approving the document, shall be documented as required by 21 CFR 820.40(a). Approval of your firm's procedure for testing the temperature of arrays did not have a signature and an effective date (FDA 483, Item #11).
Medical Device Reporting (MDR)
The above stated inspection also revealed that these devices are misbranded under section 502(t)(2) of the Act (21 USC 352(t)(2)), in that your firm failed to furnish material or information as required under section 519 of the Act and regulations implementing that section at Title 21 Code of Federal Regulations (21 CFR), Part 803 — Medical Device Reporting (MDR). More specifically your firm failed to report within 30 days, whenever you receive or otherwise become aware of information from any source that reasonably suggests that a device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). Your firm received 29 reports of burns to users of the Anodyne Therapy device from August 2003 to April 2005. At a minimum your firm failed to submit nine (9) of the reports referencing burns to users to FDA as serious injuries, e.g., Complaints #144 dated 1/2/2004, #858 dated 8/19/2004, #1014 dated 9/13/2004, #1452 dated 1/14/2005, #1457 dated 10/29/2004 concerning two patients, #1625 dated 1/14/2005, #1883 dated 3/8/2005, and #2175 4/26/2005 (FDA 483, Item #5).
Establishment Registration and Device Listing
We have reviewed your firm's Establishment Registration and Device Listing records. Although you have an active Establishment Registration under Registration Number 1055581, you previously had a duplicate Establishment Registration under Registration Number 30044562499. When this duplicate Establishment Registration was purged from our database, the associated Device Listing for an Infrared Lamp (21 CFR 890.5500) was also purged. Please submit a new FDA Form 2892, Device Listing, to include an Infrared Lamp among your Device Listings.
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 applications for premarket approval to which QS regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates for Products for Export will be granted 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 the steps you have taken to correct the noted violations, including:
- the time frames within which the corrections will be completed,
- any documentation indicating the corrections have been achieved, and
- an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure the similar violations will not recur.
Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Pl #200, Maitland, FL 32751, (407) 475-4728.
Emma K. Singleton
This page was posted on March 28, 2006.