Inspections, Compliance, Enforcement, and Criminal Investigations
AMF Support Surfaces, Inc. 08-Nov-04
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
|November 8, 2004||
Charles Curtis Wyatt
AMF Support Surfaces, Inc.
1691 N. Delilah Street
Corona, CA 92879-1885
Dear Mr. Wyatt:
During an inspection of your medical device firm located in Corona, California, from June 29-30, 2004 and July 1 and 6, 2004, our investigator determined that your firm manufactures and distributes the Cool Heat Versatility Heating Mattress System, intended for tables, gurneys, hospital beds, surgical and diagnostic surfaces in hospitals or surgical centers to prevent and treat hypothermia, and the TempurPlus 3 Advanced Therapy Mattress System, intended for lateral turning, low air loss, and alternating pressure therapy. 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)].
Our records do not reflect that you have received either premarket approval or a determination of substantial equivalence for your Cool Heat Versatility Heating Mattress System. Consequently, that device is adulterated under Section 501(f)(1)(B) [21 U.S.C. 351(f)(1)(B)] of the Act in that it is a Class III device under Section 513(f) [21 U.S.C. 360c(f)] and does not have an approved premarket approval application (PMA) in effect under section 515(a) [21 U.S.C. 360e] or an approved application for an investigational device exemption under 520(g) [21 U.S.C. 360j(g)] of the Act.
The Cool Heat Versatility Heating Mattress System is also misbranded under Section 502(o) [21 U.S.C. 352(o)] of the Act in that a notice or other information respecting the device was not provided to the Food and Drug Administration 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).
In addition, our inspection disclosed that both the Cool Heat Versatility Heating Mattress System and the TempurPlus 3 Advanced Therapy Mattress System devices are adulterated within the meaning of Section 501(h) [21 U.S.C. 351(h)] of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, and storage are not in conformance with the Good Manufacturing Practice (GMP) requirements for the Quality System Regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
1. Failure to fulfill management quality system responsibilities as required by 21 CFR 820.20. For example,
- Failure to establish procedures for conducting management reviews, as required by 21 CFR 820.20(c) & 820.20(e).
- Failure to appoint, and document appointment of, a management representative to ensure that quality system requirements are effectively established and maintained and to ensure the reporting on the performance of the quality system activities to management with executive responsibility, as required by 21 CFR 820.20(b)(3).
2. Failure to conduct and document audits to verify that the quality system is effective in fulfilling the quality system objectives, as required by 21 CFR 820.22. Specifically, no quality audits had been conducted since December 2002.
3. Failure to establish and maintain procedures for receiving, reviewing and evaluating complaints by a formally designated unit to ensure that all complaints are processed in a uniform and timely manner, as required by 21 CFR 820.198. Additionally, no procedures have been established to determine whether a complaint represents an event which is required to be reported under 21 CFR part 803, Medical Device Reporting, as also required by 21 CFR 820.198.
4. Failure to document the evaluation and investigation of nonconforming product, as required by 21 CFR 820.90(a). Specifically, 6 of 8 nonconforming rejected product reports did not include documentation of evaluation and investigation into the cause of the nonconformance.
5. The Device History Records for the Cool Heat Versatility Heating Mattress System Control Unit are not adequate. They do not include the manufacturing dates and primary identification label and labeling for each device, as required by 21 CFR 820.184(a) and 21 CFR 820.184(e). Specifically, 11 of 11 Device History Records for the Cool Heat Versatility Heating Mattress System Control Unit did not include the manufacturing dates and primary identification label and labeling for each device.
6. Failure to establish and maintain a device master record for the Cool Heat Versatility Heating Mattress System, as required by 21 CFR 820.181.
7. Failure to establish procedures to control the design of devices manufactured by your company, as required by 21 CFR 820.30. Specifically, while you pointed to some design control procedures during the inspection, and to others in your written response, these were unsigned and are not in effect.
8. Failure to establish and maintain procedures for acceptance or rejection of incoming product to ensure that all incoming product is inspected, tested, or otherwise verified as conforming to specified requirements, as required by 21 CFR 820.80(b). Specifically, you do not have procedures for receiving and acceptance/rejection of display boards, logic boards and fiber optic boards used to manufacture the Cool Heat Heating Mattress System.
9. Failure to establish and maintain procedures to ensure that inspection, measuring, and test equipment is routinely calibrated, as required by 21 CFR 820.72(a). Specifically, there were no procedures for calibration of the magnahelic gauge and voltage meter used for the in-process testing of the TempurPlus3 Advanced Therapy Mattress System power unit (blower) subassemblies.
10. Failure to document on the calibration records equipment identification, calibration dates, the individual performing each calibration, and the next calibration date, as required by 21 CFR 820.72(b)(2). Specifically, you do not have calibration records for the magnahelic gauge and voltage meter used for the in-process testing of the TempurPlus3 Advanced Therapy Mattress System power unit (blower) subassemblies.
11. Failure to have purchasing documents that includes an agreement that the suppliers, contractors, and consultants notify the manufacturer of changes in the product or service so that manufacturer may determine whether the changes may affect the quality of a finished device, as required by 21 CFR 820.50(b).
We acknowledge receipt of your letter dated August 5, 2004 in which you responded to the observations delineated on the form FDA 483 issued to you on July 7, 2004. This response is inadequate because it does not provide any supporting documentation of any proposed or corrective measures undertaken by your company to correct the observations and prevent the recurrence. In addition, while the letter indicates that corrective measures will be undertaken for each observation, a majority of these corrections are scheduled for completion in the year 2005. You do not provide an explanation why the observations could not be addressed in a more timely manner. We consider this schedule unacceptable because these activities should have already been controlled and the performance of those activities documented.
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. The specific violations noted in this letter and in the Form FDA 483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your firm’s manufacturing and quality assurance system. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be systems problems, you must promptly initiate permanent corrective actions.
Federal Agencies are advised of the issuance of all Warning Letters pertaining to medical devices so that they may take this information into account when considering the award of contracts. Additionally, no applications for premarket approval for devices to which the GMP deficiencies are reasonably related will approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected.
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.
You should notify this office within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations including an explanation of each step being taken to identify and prevent the recurrence of similar violations. If corrective action cannot be completed within (15) working days, state the reason for the delay and the time within which the corrections will be completed.
If you have any questions regarding this letter, please contact Mariza M. Jafary, Compliance Officer at 949-608-2977.
Your written reply should be addressed to:
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2446
Alonza E. Cruse
State Department of Public Health
Environmental Health Services
Attn: Chief Food and Drug Branch
601 North 7th Street, MS-35
Sacramento, CA 94234-7320