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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CareFore Medical Incorporated 10-Jan-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration



January 10, 2006



Ref. KAN 2006-10

Sean C. Squire, President
CareFore Medical Incorporated
11605 South Alden Street
Olathe, Kansas 66062-6924

Dear Mr. Squire:

Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340
Telephone : (913) 762-2100

During an inspection of your establishment located in Olathe, Kansas, completed on October 13, 2005, our investigator determined that your establishment manufactures oxygen concentrator inlet filters . These filters 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 these devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for 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 OS and MDR Regulations violations including, but not limited to, those described below:

Quality System Regulation

  1. Failure to establish, document, and implement a design and development plan, as required by 21 CFR 820.30(b). Specifically, the oxygen concentrator inlet filters CF 500, CF 600, and CF 700 do not have written design plans defining the development process of the devices. [FDA-483 Item 1]

2. Failure to establish and maintain a design history file, as required by 21 CFR 820.300). Specifically, the CF 500, CF 600, and CF 700 filters do not have any written documents to demonstrate the devices were developed according to a design plan and that design requirements for the filters were met. [FDA-483 Item 2]

3. Failure to document approval of design input requirements, as required by 21 CFR 820.30(c). Specifically, the CF 500, CF 600, and CF 700 filters do not have any documentation of their approved design specifications, including the date and signature of the individual approving the requirements. There is no documentation showing the intended use, performance characteristics, risk, human factors and compatibility with the environment of intended use. [FDA-483 Item 3]

4. Failure to establish and maintain procedures for verifying the device design, as required by 21 CFR 820.30(f). Specifically, there is no documentation of design verification activities for the CF 500, CF 600, and CF 700 filters confirming that design output meets the design input requirements. [FDA-483 Item 4]

5. Failure to establish and maintain procedures for acceptance of incoming product, as required by, 21 CFR 820.80(b). Specifically, there are no written component specifications or acceptance procedures for components of the CF 500; CF 600, and CF 700 filters or the CPAP head gear straps. [FDA-483 Item 5]

6. Failure to establish and maintain procedures that define the review and disposition o f nonconforming product, as required by 21 CFR 820.90(b)(1), Specifically, there are no written procedures defining the control and disposition of nonconforming components and finished devices. [FDA-483 Item 6]

7. Failure to adequately analyze appropriate sources of quality data to identify existing and potential causes of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(1). Specifically, a defined statistical methodology has not been established in your, corrective and preventive action (CAPA) procedure for analyzing recurring quality data to detect quality problems. [FDA-483 Item 7]

8. Failure to define and implement procedures addressing identification of corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically, the Standard Operating Procedure, Policy number QS-100 - Corrective and Preventive Action does not sufficiently describe in detail if failure investigation procedures are followed; determine if appropriate sources of product and quality problems have been identified; and if appropriate actions have been taken for significant product and quality problems. [FDA-483 Item 8]

Medical Device Reporting

9. Failure to develop and implement written Medical Device Report (MDR) procedures, as required by, 21 CFR 803 .17. Specifically, there are no written procedures defining the timely and effective evaluation of reportable MDR events and the criteria for identifying such events and reporting them to the FDA. [FDA-483 Item 9]

Additionally, although not noted on the FDA-483, the failure to submit a 510K_report on the filter devices (CF 500, CF 600, CF 700) causes them to be misbranded devices under Section 502(o) of the Act (21 U.S .C. 352(o)) . The filters that your firm manufactures are Class II medical devices subject to performance standards.

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 establishment's quality system. You are responsible for investigating and determining the causes of the violations identified by the FDA.

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 submissions for Class III devices to which the Quality System/GMP deficiencies are reasonably related will be cleared or 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 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.

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 that indicates 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 Joseph G. Kramer, Compliance Officer, Food and Drug Administration, at the address noted in the letterhead.

John W. Thorsky
Kansas City District
District Director