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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ludwig Medical, Inc 13-Aug-03

Department of Health and Human Services' logo

Public Health Service
Food and Drug Administration

    550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863


August 13, 2003





Gerald E. Ludwig, President
Ludwig Medical, Inc.
1010 Parkview Street
Effmgham, IL 62401
Dear Mr. Ludwig:

During the inspection of your firm from May 19 to May 21,2003, Investigator James L. Finn determined that your firm manufactures specimen traps, labeled as sterile. Specimen traps are devices as defined by Section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321(h)).

This inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act (2 1 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, as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:

1.? Failure to conduct quality audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. For example, your firm did not conduct a quality audit since 1991. [21 CFR 820.22.]

2.      Failure to validate the following manufacturing processes whose results cannot be verified by subsequent inspection and test. For example, your firm did not validate the following processes (2 I CFR $820.75(a)]:

    1. ?        Gamma irradiation of products labeled as sterile
    2. ?        ?Heat sealer used to seal packages labeled as sterile
    3. ?        Resterilization {reprocessing) of products labeled as sterile

    3.      Failure to develop, conduct, control, and monitor production processes to ensure that devices conform to specifications. For example [21 CFR 820.70(a)]:

    1. ?        ?Pre-sterilization package integrity testing consists only of selecting one sample per each [redacted] packages and performing visual examination of seal after pulling apart.
    2. ?        No post-sterilization package integrity testing was performed.
    3. ?        Bioburden levels of product irradiated and labeled as sterile were last determined 12/3/92.
  1. ?        No bioburden upper limit was established.

4. Failure to establish and maintain procedures for acceptance of incoming product. For example, your firm did not establish acceptance procedures for the receipt of packaging material and other components. [21 CFR 820.80(b)]

5.      Failure to establish and maintain procedures for implementing corrective and preventive action. [21 CFR? 820.100(a)]

6.      Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation. For example, documented changes to the specifications of test tubes were not validated or verified. [21 CFR 820.30(i)]

7.      Failure to establish and maintain procedures for acceptance or rejection of finished device production runs, lots, or batches. [21 CFR 820.80(d)]

8.      Failure to establish and maintain procedures to ensure and determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting. [21 CFR 5 820.198(a)(3)]

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 to you at the close of the inspection may be symptomatic of serious underlying problems in your firm?s manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the Food and Drug Administration (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 about devices so that they may take this information into account when considering the award of contracts. No premarket submissions for Class III devices, to which the Quality System/Good Manufacturing Practice deficiencies are reasonably related, will be cleared or approved until the violations have been corrected. Additionally, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected and verified.

We acknowledge receipt of your firm?s response, dated June 4,2003, to the FDA-483. We do not consider your responses to be adequate because of the following:

FDA-483 # 1 Response:

You proposed that you, individually, be allowed to conduct a ?self-audit.? This is not adequate because the Quality System Regulation [21 CFR 820.22, Quality Audit] specifically states, ?Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited.? During the inspection, our investigator observed that your responsibilities include oversight of all operations, all regulatory concerns, quality assurance, and training/monitoring of employees.

FDA-483 # 2 Response:

This response is not adequate because you did not indicate that your sample quantity is based on a valid statistical rationale. Using valid statistical techniques to choose sample quantities is required by 21 CFR 820.50, Statistical Techniques.

We therefore request that you implement additional measures to address these deviations. Your letter also promised to address the other deviations and we request that you do so promptly. Failure to promptly correct these deviations may result in regulatory action being initiated by FDA without &tier notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.

Please notify this office, in writing, within 30 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 make corrections to any underlying systems problems necessary to assure that similar violations will not recur. If corrective action cannot be completed within 30 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to Michael LKang, Compliance Officer. If you have any questions regarding this letter, please contact Mr. Lang at (312) 596-4225.



Arlyn H. Baumgarten

District Director