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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Riemer MediTech GmbH 11-Apr-03

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

Public Health Service
Food and Drug Administration

 

Center for Devices and
Radiological Health
2098 Gaither Road
Rockville, Maryland 20850


APR 11 2003

VIA FEDERAL EXPRESS

WARNING LETTER

Antoni S.H. Riemer, Managing Director
Riemer MediTech GmbH
Lautertalweg 12, Postfach 1173 (D-89130)
D-89134 Blaustein (Ulm)
Federal Republic of Germany

Dear Hr. Riemer:

During an inspection of your firm located in Blaustein, Germany, November 4 through November 7, 2002, our investigator determined that your firm manufactures muscle stimulators. These products are medical devices under the Federal Food, Drug, and Cosmetic Act (the Act), because they are intended for use in diagnosing or treating a medical condition or to affect the structure or a function of the body (Section 201(h) of the Act, 21 U.S.C. Section 321(h)).

This inspection revealed that these medical devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C. Section 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) of the FDA's Quality System Regulation as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as listed below:

1. Failure to establish and maintain adequate procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30. For example:

a.) Your firm could not provide any documented evidence of device software validation for version [redacted], which is used for the production of all units made at Riemer MediTech, and currently being imported into the U.S. 21 CFR 820.30(g). This [redacted] is used in both the PRO GeneSys 2 and PRO GeneSys Combo.

During your response to the investigator, you indicated that you only use what you were instructed to use and never received any records or written authorization which demonstrated that this version of software was validated or otherwise acceptable for use. You promised to contact [redacted] and obtain proof that the software in use is a validated product.

Your response is inadequate in that your firm will need to provide documentation of the validation of the software to correct this deficiency, since you are the manufacturer importing these products into the U.S. Since you are importing these products, Riemer MediTech is responsible for all the Quality System Regulation requirements.

b.) PRO GeneSys 2 and PRO GeneSys Combo are sold in the United States by [redacted] but are labeled as manufactured by Riemer MediTech. You have failed to establish and maintain procedures to control the designs of PRO GeneSys 2 and PRO GeneSys Combo. 21 CFR 820.30(a).

During your response to the investigator you promised to contact [redacted]
Your response is inadequate in that you will need to provide documentation of the correction of this deficiency.

c.) Procedure [redacted] does not provide for adequate design control of changes made to existing specifications. 21 CFR 820.30(i).

During your response to the investigator, you responded by changing the SOP to state [redacted]

Your response is inadequate and unverifiable as the SOP is written in German. The firm will have to send a translated copy of the SOP.

2. Failure to maintain an adequate Device Master Record (DMR) which includes or refers to the location of such things as device specifications, production process specifications, quality assurance procedures and specifications, packaging and labeling specifications, and maintenance procedures and methods, as required by 21 CFR 820.181. For example, the software specification, drawings for the printed circuit boards (mother board and DSP boards), wiring configurations, component specifications, production specifications, quality assurance procedures and specifications, etc., that relate to the PRO GeneSys 2 and PRO GeneSys Combo, do not exist in a form which link them together and do not refer to the specific documents or location.

In your response to the investigator, you stated that you understood the requirements and would contact [redacted] to obtain the DMR and necessary approvals for the contract manufacturers of the component in writing. You stated that you would explore obtaining a new contract with [redacted]

Your response is inadequate in that you need to provide documentation to FDA to prove that these corrective actions have been taken.

3. Failure to include the document approval date and the signature of the approving official in the documentation of approval of documents, as required by 21 CFR 820.40(a). For example, the documents, e.g., software specifications, drawings for printed circuit boards, wiring configurations, component specifications, production process specifications, quality assurance procedures and specifications for the products, PRO GeneSys2 and PRO GeneSys Combo, do not have approval signatures and dates associated with the DMR.

In your response to the investigator, you stated that you understood the requirements and would contact [redacted] to obtain the DMR and necessary approvals for the contract manufacturers of the component in writing. You stated that you would explore obtaining a new contract with [redacted]

Your response is inadequate in that you need to provide FDA with documentation to prove that these corrective actions have been taken.

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 FDA-483 issued at the closeout 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 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 government contracts. Also, no requests for Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected.

Given the serious nature of these violations of the Act, the devices manufactured by Riemer MediTech may be detained without physical examination upon entry into the United States (U.S.) until these violations are corrected.

In order to remove the devices from this status, it will be necessary for you to provide a written response to the charges in this Warning Letter for our review. After we notify you that your response is adequate, we will request a reinspection of your facility. As soon as the re-inspection has taken place, the implementation of your corrections has been verified, and you are notified that your corrections are adequate, your devices may resume entry into this country.

Please notify this office in writing 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. Please include any and all documentation to show that adequate correction has been achieved. In the case of future corrections, an estimated date of completion, and documentation showing plans for correction should be included with your response to this letter. Please address your response to:

Donald W. Serra, Chief
Cardiovascular and Neurological Devices Branch (HFZ-341)
Center for Device and Radiological Health
Office of Compliance
Division of Enforcement III
2098 Gaither Road
Rockville, MD 20850
USA

If you need help in understanding the contents of this letter, please contact Donald W. Serra at the above address or at (301) 594-4648 or FAX (301) 594-4672.

You may obtain general information about all of FDA's requirements for manufacturers of medical devices by contacting our Division of Small Manufacturers, International and Consumer Assistance (DSMICA, formerly DSMA) at (800) 638-2041, or through the Internet at http://www.fda.gov.

Sincerely yours,

/S/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health