|Subject:||Promotional Claims/New Drug/Misbranded|
|Issuer:||Kansas City District Office|
|Issued:||June 28, 2005||Closed:||
Department of Health and Human Services
Public Health Service
Kansas City District
June 28, 2005
RETURN RECEIPT REQUESTED
Ref. KAN 2005-12
Mr. David G. Van Gorp
President and Chief Executive Officer
1401 8th St.
P.O. Box 320
Orange City, IA 51041
Dear Mr. Van Gorp:
During an inspection of your establishment located- in Orange City, Iowa, conducted April 25 through May 12, 2005, our investigator determined that your establishment manufactures various radiation therapy products including patient positioning and fixation systems and brachytherapy equipment. 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)].
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 Quality System regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR); Part 820, as follows:
• Management with executive responsibility has not ensured that the quality policy has been fully implemented and maintained at all levels of the organization and. satisfies the, requirements of the quality system regulations. [21 CFR 820.20(a))
• Failure to,establish an effective corrective and preventative action system [21 CFR 820.100].
a) Your firm has no documentation of having performed any trending or other analysis, such as statistical methods; to analyze product or quality problems.
b) Your firm does not analyze and compare different data sources, such as complaints, scrap reports, deviation logs, rework; etc., to detect recurring quality problems.
c) Your firm has identified two problems with your patient immobilization system, #MT-VL, a class II medical device; leaking valves and pinholes. However, your firm has no, documentation indicating any investigation has been conducted for these problems or what corrective action is being taken.
d) Your firm has not established procedures for use to conduct periodic trending analysis associated with your firm's Return Materials Authorization (complaint) forms, scrap reports and Deviation Log, nor does your firm conduct any periodic trending in association with their complaints/nonconformance activities.
• Failure to maintain complete complaint investigation. records. [21 CFR 820.198(e)]. Your firm has no documentation of any investigation being conducted or documentation of what corrective actions were taken, dates or results of any investigations.
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. You also must promptly initiate permanent corrective, and preventive, action on your. Quality System.
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.
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.
Our office is in receipt of your letter dated May 17, 2005 in which you outline your Plans for corrective actions. We are also in receipt of your letter dated June 3, 2005 which offers more confirm in writing the status of your corrective actions and your systems, review within fifteen days of receipt of this letter. Your response should be sent to Nadine Nanko Johnson, Compliance Officer at the above address.
John W. Thorsky