| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
Yacov Bubis
Senior Vice President, Chief Operating Officer
Oridion Medical 1987 Ltd.
7 Hamarpe St., P.O. Box 45025
Har Hotzvim Industrial Park
Jerusalem, 91450
Israel
OCT 4 2011
Dear Mr. Bubis:
During an inspection of your firm located in Jerusalem, Israel, on June 12, 2011, through June 15, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the MicroStreamCO2 Filterline. Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
This inspection revealed that this device is 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 its manufacture, 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 (CFR), Part 820. These violations include, but are not limited to, the following:
Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, specified requirements, including quality requirements, were not established or maintained for your firm's contract manufacturer, (b)(4).
(b)(4) is responsible for manufacturing, finished device testing, and maintenance of Device History Records. Neither your firm nor (b)(4) could account for all units of (b)(4) that were produced at (b)(4). Specifically, Device History Records were requested for review but were not provided during the inspection, nor was information provided that demonstrated (b)(4) maintains Device History Records for your firm's devices.
For (b)(4) nonconforming (b)(4) units in (b)(4) disposition was documented with a retrospectively created Certificate of Destruction, dated (b)(4). Documented data, such as production or acceptance records, to confirm the disposition of all nonconforming product, were not available.
Inadequate quality controls were maintained in that incomplete (b)(4) instructions for the nonconforming (b)(4) were provided to (b)(4), your firm's contract manufacturer. The (b)(4) Instruction, dated March 23, 2011, called for (b)(4) to (b)(4). There were no requirements that these (b)(4) activities be documented and maintained in the Device History Record. Since the original lot number was to be used, there was no way of identifying the units which were (b)(4). The (b)(4) procedure required the (b)(4) products to be (b)(4) according to (b)(4). There was no assurance the (b)(4) test adequately evaluated the potential of any adverse effect upon the (b)(4). Your firm has not established that this testing be documented.
Given the serious nature of the violation of the Act, the MicroStream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate) manufactured by your firm is subject to refusal of admission under section 801 (a) of the Act, 21 U.S.C. § 381 (a), in that it appears to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the device from detention, your firm should provide a written response to this Warning Letter as described below and correct the violation described in this letter. We will notify your firm if your firm's response appears to be adequate and we may need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violation related to the subject device has been corrected.
Please notify this office in writing within fifteen business days from the date your firm receives this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the
time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your firm's response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, W066-2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case 219475 when replying. If you have any questions about the contents of this letter, please contact: H. Charles Cathlin Jr., Chief, Radiology, Anesthesiology, and Neurology Devices Branch, at (301)796-5548 or via facsimile at (301)847-8128.
Finally, your firm should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and Radiological Health
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