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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Kincaid Coach Lines, Inc. 13-Aug-02

Department of Health and Human ServicesDepartment of Health and Human Services            Public Health Service


Food and Drug Administration
Kansas City District
Southwest Region
11650 West 60 Street
P.O. Box 15905
Lenexa, Kansas 66265-4905
Telephone: (913) 752-2100

August 13, 2002
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref. KAN 2002-10

Mr. Graydon J. Kincaid, Jr., President
Kincaid Coach Lines, Inc.
c/o Midwest Bus Sales
313 East Front Street
Bonner Springs, KS 66012

Dear Mr. Kincaid:

FDA inspected your facility, Kincaid Coach Lines, Inc., located at 9207 Woodend Rd., Edwardsville, KS on July 25, 2002. The observations made during the inspection are in violation of the Public Health Service Act, 42 U.S.C. 201, et seq., the Food Drug and Cosmetic Act, 21 U.S.C. 301, et seq., and the accompanying regulations promulgated in Title 21, Code of Federal Regulations, Parts 1240 and 1250.

During the inspection the following violations were noted:

  • No backflow prevention device was installed on the hydrant used to clean the hopper area and fill bus toilet system. [21 CFR 1250.75(b)]
  • The surface area around the hopper was not sloped to drain and was not kept clean. [21 CFR 1250.65]

The list of inspectional observations, identified above, is not intended to be an all-inclusive list of the conditions observed at your facility. It is your responsibility to assure adherence with all requirements of the regulations at this facility, and any other facilities involving interstate travel and sanitation under your control.

Based on the inspectional findings, we are classifying your facility as PROVISIONAL for interstate carrier use for a period of three (3) months. A PROVISIONAL classification means that the facility may continue to operate; however, significant correction of violations must be made by the expiration date. On or about that date, a re-inspection of this facility will be conducted to assure that corrections meet FDA requirements. If significant corrections are not made the time of the next inspection, the facility will be reclassified as NON-APPROVED for carrier use.

Please advise this office within fifteen (15) days of the receipt of this letter regarding the measures you have implemented to correct the violations. Your response should include a discussion of any delays you foresee in achieving correction, and a deadline by which correction can be expected. Please direct your response to Nadine Nanko Johnson, Compliance Officer at the address listed above.

Sincerely,

/s/

Charles W. Sedgwick

District Director

Kansas City District