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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Smith Medical Critical Care, Inc. 05-Sep-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

September 5, 2006




Stuart Morris-Hipkins
Smith Medical Critical Care, Inc.
10 Bowman Drive
Keene, NH 03431-5043

Dear Mr. Hipkins:

During an inspection of Medex Inc., located at 6250 Shier-Rings, Dublin, OH 43016 on March 20 through April 6, 2006, our investigator determined that Medex, Inc., which is owned by your company, manufactures Anesthesia Sets with Needle-less Split Septum Injection Sites and Intravascular Administration (IV) Sets with Needle-less Split Septum Injection Sites. 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.

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, their manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Cathy Chenetski, VP of Quality Assurance and Regulatory Affairs, dated April 27, 2006, and two additional responses from Margaret Lowry, Quality Assurance Manger, dated June 30 and August 1, 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 validate the design to ensure that the device conforms to the defined user/patient needs and intended uses as required by 21 CFR 820.30(g). For example, the Needle-less Split Septum Injection Site design validation did not show that the design input requirement of being able to function fully with any access cannula was met. The validation testing was only conducted using one type of cannula. There is no objective evidence that testing conducted using this one type of blunt cannula is representative of the blunt cannulas made by other manufacturers. Additionally, your risk analysis stated that one of the hazards was that the housing of the pre-split septum could come apart or- crack, and this hazard was to be mitigated by testing the septum with multiple style cannulas. This testing was not performed.

2) Failure of the verification testing to confirm that the design outputs meet the design input requirements as required by 21 CFR 820.30(f). For example, the Needle-less Split Septum Injection Site design verification did not confirm the following:

- The requirement of a minimum flow rate of 100 psi (for 15 seconds after 100 activations) was not verified.
- The requirement of luer taper standards where applicable (ISO 594/1 and 594/2) was not verified.

3) Failure to completely identify the design inputs and outputs that are essential for the proper functioning of the device as required by 21 CFR 820.30(c) and (d). For example, the Needle-less Split Septum Injection Site design project did not include documented requirements for the following as inputs and outputs:

- Pull testing was performed during verification testing, but this requirement was not included in any input and/or output documents;
- Peak force value as the full length of the cannula is inserted into the Needle-less Split Septum Injection Site was tested during verification, but this requirement was not included in any input and/or output documents.

4) Failure to have a mechanism for addressing incomplete, ambiguous and conflicting design input requirements in your design procedures, as required by 21 CFR 820.30(c).

The response letters stated that for all observations that pertained to the Anesthesia and Intravascular Administration Sets with Needle-less Split Septum Injection Site design project, that Medex would review all derivative pathway design control project files and would complete the review by September 1, 2006. Please provide an update on the status of this review.

Ms. Lowry's response letter dated August 1, 2006 stated that the entire design control process has been reviewed and changes have been implemented. This included modifying the design control procedure to require that all incomplete, ambiguous and conflicting design input requirements are addressed. We will evaluate the adequacy of this response during the next FDA inspection of your facility. Until then, no further response is necessary with regard4o this violation.

5) Failure to investigate and take corrective and/or preventive action on quality data that can be potential causes of nonconforrn.ing product, as required by 21 CFR 820.100(a)(1) and (2). For example, bioburden test data for the 2G family of products was 14 CFUs, which is above the alert limit of 7 CFUs. You did not follow the "Bioburden Testing" procedure, which requires the identification of the prevalent organism if the samples exceed the alert limit. Also, the sump temperatures of the injection molding machines for March 17-23, 2006, were above the required 104°F-122°F. No investigation and corrective action was performed:

Ms. Chenetski's response letter stated that the employees in these two areas have been retrained. Additionally, the preventive maintenance program for the sump temperature of the injection molding machines has been changed to require the machine to be shut down if the temperature is out of specification. We will evaluate the adequacy of this response during the next FDA inspection of your facility. Until then, no further response is necessary with regard to this violation.

6) Failure to ensure that all personnel are trained to adequately perform their assigned responsibilities as required by 21 CFR 820.25(b). For example, of the 13 training records reviewed by our investigator, 5 of the employees that work in the injection molding area did not receive the training on nonconformances found during reviews of complaints or product defects related to their job functions.

Ms. Chenetski's response letter states that the training procedure has been changed to assure that any employees who are absent the day of training receive the training. The departmental management will be responsible for providing training when that person returns to work and all supervisors in the department that were not providing training to absent employees have been retrained on the procedure. Additionally, the letter states that training records for all the employees in this department are being reviewed and if the review finds that any employees missed a training session, they will receive the training. The response stated that these steps would be completed by June 1, 2006. Please provide an update on the status of this review and training.

Our inspection also revealed that Medex's Anesthesia and Administration sets with needle-less access port containing pre-split septum, that your firm has distributed since January l, 2005, are adulterated under section 50l(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), in that they are class III devices under section 513(f), 21 U.S.C. 360c(f), and do not have an approved application for premarket approval in effect pursuant to section 515(a), 21 U.S.C. 360e(a), or an approved application for investigational device exemption under section 520(g), 21 U.S.C. 360j(g).The devices are also misbranded under section 502(o), 21 U.S.C. 352(o), in that a notice or other information respecting the devices was not provided to the FDA, as required by section 510(k), 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html.The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

Our inspection further revealed that Medex's MX441B CVP Manometer and MX6160R1 Ciper devices are misbranded within the meaning of section 502(t)(2) of the Act in that the firm failed or refused to furnish any material or information required by or under section 519, 21 U.S.C. 360i, respecting the device and 21 CFR Part 806 (Reports of Corrections and Removals)., On November 18, 2005, Medex Inc. sent a letter to all consignees requesting them to return the Manometer and Ciper devices because the devices are labeled "Latex Free". However, one of the components (adhesive tape) of these devices contained latex. FDA determined that these actions represent Class II recalls. The Manometer is class II under recall #Z-0812-06 and the Ciper is class 11 under recall #Z-0811-06.

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. (21 CFR 806.10 (a)(1)). Such report must be submitted to FDA within 10 days of the correction or removal. (21 CFR 806.10(b)). Because your firm's action described above meets the definition of a "removal" in 21 CFR 806.2(i) and because it was initiated to reduce a risk to health posed by the device, your failure to report it until the issue was raised by our investigator violated 21 CFR 806.10(a)(1). The FDA was not aware of the two recalls until March 28, 2006.

This letter is not intended to be an all-inclusive list of violations at Medex's 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 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in 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 the firm's 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.

Please notify this office within fifteen (15) working days from the date you received this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include all documentation of the corrective action you have taken. 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 letters, 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) 679-27Q0, ext. 167, or you may forward a facsimile to her at (513) 679-2773.



Carol A. Heppe
District Director
Cincinnati District