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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Radiometer America, Inc. 12-Oct-06

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

Public Health Service
Food and Drug Administration


Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone : (513) 679-2700
FAX: (513) 679-2771

October 12, 2006


Lynda C . Banig
Radiometer America, Inc.
810 Sharon Drive
Westlake, OH 44145-1598

Dear Ms. Banig:

During an inspection of your medical device manufacturing facility located at 810 Sharon Road, Westlake, OH conducted by our investigator on March 10, 13-16, 22-24, April 4-6 and May 3-5, 11, 12, 23-25, 2006, revealed that your firm is responsible for sales, marketing, distribution, complaints, servicing and failure investigations for all blood-gas analyzers, transcutaneous monitors, syringe product line, QC reagents, and integration software for the blood gas analyzers distributed in the United States and Canada that are manufactured by your parent company Radiometer Medical, ApS, Bronshoj, Denmark. Under section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

This 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 conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. We received the responses from you dated June 5 and September 12, 2006 concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1) Failure to investigate complaints involving the possible failure of a device to meet its specifications; and failure to describe when and how failure investigations are conducted in your complaint handling procedure. [21 CFR 820.198(c) and (a)]

Specifically, of the 18 complaints reviewed by the investigator, three Techline Reports and six "BAS" Reports had incomplete failure investigations. Your responses state that you have updated your Complaint Reporting Procedure and Customer Complaint System (BAS), and are trending service work orders and complaints monthly to assure that all complaints are fully investigated . You have also trained personnel on the revised complaint hpndling system and the complaint investigation procedure. We will evaluate the adequacy of this response during the next FDA inspection of your facility.

2) Failure to maintain complete complaint files. [21 CFR 820.198(a)]

Specifically, 10 of the 12 closed complaint files reviewed were incomplete . Two of the files did not contain a documented determination on whether a Health Hazard Assessment was necessary; and eight of the files did not document the codes for the "Primary Fault Action" and/or "Primary Fault Part No.", which is used by your firm for quality trending.

Your responses state that you have revised your "Service, Repair, Work Order Completion Processing" procedure to assure all complaint files are complete. You have also trained personnel on the revised complaint handling procedures . We will evaluate the adequacy of this response during the next FDA inspection of your facility.

3) Failure to define and complete complaint handling procedures to ensure that all complaints are evaluated to determine whether the complaint should be filed as a Medical Device Report (MDR). [21 CFR 820.198(d)]

Specifically, your firm's complaint handling procedures do not have a mechanism for reviewing malfunctions to determine if a malfunction would be likely to cause or contribute to a death or serious injury if the malfunction would recur.

Your response, dated June 5, 2006 states your firm has revised the Complaint Reporting and Service Repair Work Order Completion and Processing procedures to include provisions for evaluating malfunctions to determine if a MDR should be filed. You have also trained personnel on the revised complaint handling procedures . We will evaluate the adequacy of this response during the next FDA inspection of your facility.

Our inspection also revealed that your blood gas analyzer devices are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed to or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i and 21 C.F.R. Part 806 - Reports of Corrections and Removals regulation. Significant deviations include, but are not limited to, the following:

  • Failure to submit a written report to FDA regarding the correction that your firm made to the capillary end caps, which are accessories for use with blood gas analyzer devices included in your CLINITUBES kits, as required by 21 C.F.R. Part 806.10. This correction was initiated to remedy a violation of the Act caused by the device which may present a risk to health. On March 22, 2006, your firm sent a recall letter, accompanied by a bag of new end-caps, to customers that own a Radiometer blood gas analyzer . The letter notified your customers of a "leakage" problem with the capillary (end) caps, and asked them to discard all of the end-caps on hand.

  • Failure to submit a written report to FDA regarding the correction that your firm made to the waste tubing, which are accessories used with your ABL 700/800 Blood Gas Analyzer devices, as required by 21 C.F.R. Part 806.10. On February 20, 2006, your firm sent a "Field Action Rationale Form" (15-232) requesting that all distributors discard their stock of all affected waste tubes and to replace those already placed at customers stock or installed in analyzers. You recalled this tubing as a result of Field Service Personnel complaints on the tubing leaking blood and solution, and your internal failure investigation revealing that during installation of the waste pump tubing, the tubing pulls out of the black plastic adaptors.

FDA regulations require manufacturers and importers to submit a written report to FDA of any correction or removal of a device if the correction or removal was initiated to reduce a risk to health posed by the device. See 21 CFR 806.10 (a)(1). This report must be submitted to FDA within 10 days of initiating the correction or removal. See 21 C.F.R 806.10(b). Because your actions described above meet the definition of a "correction" in 21 CFR 806.2(d) and because they were initiated to reduce a risk to health, your failure to report them until the issue was raised by our investigator violated 21 CFR 806.10(a)(1).

Your June 5, 2006 response letter states that your firm has revised your Corrections and Removals Procedure that requires all recalls, including Class III recalls be reported to the FDA. We will evaluate the adequacy of this response during the next FDA inspection of your facility.

This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 issued at the closeout of the inspection may be symptomatic of serious 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. 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 applications for Class III devices to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected.

You should continue to take prompt action to correct any and all 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 money penalties.

Your June 5, 2006 response states that you will report all recalls to FDA. You also provided a copy of your revised Correction and Removal procedure and a revised Health Hazard Evaluation. This evaluation now includes a section for documenting the rationale for when not to report a market withdrawal to FDA. In Part B, Reference #6 of this evaluation form, it states "Is the labeling adequate?" and if the answer is no an Advisory Notice is issued. Please provide clarification on whether the action of sending an advisory notice , which you define as "a customer document that contains technical information about a vulnerability or potential issue", can be classified as a recall .

In addition, please notify this office within fifteen (15) working days of any additional corrective and preventive actions you have taken for the noted deficiencies. For all of the corrective actions that you have already addressed, we will evaluate the adequacy of their implementation during the next FDA inspection. If corrective action cannot be completed within the timeframes specified in your letter, state the reason for the delay and the timeframe within which the corrections will be completed.

Your response should be sent to Ms . Gina Brackett, Compliance Officer, Food and Drug Administration 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679-2700, ext. 167, or you may forward a facsimile to her at (513) 679-2773.



Carol A. Heppe
District Director
Cincinnati District