Riverpoint Medical, LLC 5/1/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
May 1, 2013
In reply refer to Warning Letter SEA 13-19
Patrick J. Ferguson
President and CEO
825 NE 25th Avenue
Portland, Oregon 97232
Dear Mr. Ferguson:
During an inspection of your firm located at 825 NE 25th Avenue, Portland, Oregon,January 25, 2013, through February 4, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures sutures, biopsy needles, brachytherapy needles, and surgical lighting. 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 to affect the structure or any function of the body.
The 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 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.
We received a response from you dated February 22, 2013, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations. We address the response below, in relation to each of the noted violations.
Your firm’s violations include, but are not limited to, the following:
1. Failure to adequately document corrective and preventive action activities and/or results, as required by CFR 820.100(b). For example:
a) You opened CAPA #020-2011 on December 30, 2011, for brachytherapy applicator needles with exposed needle tips with the potential to damage sterile barrier pouches. The CAPA actions included revised work instructions and training for applicator needles placed in sheaths. There was no documentation of the verification or validation that these activities were completed when the CAPA was closed.
We have reviewed your response and have concluded that the adequacy of your response cannot be determined at this time because you failed to include the documentation of the revised work instructions and training in your response.
b) CAPA #017-2011 required your firm to monitor at least (b)(4) months of incoming receiving records for verification that received components met all specifications, and that the findings will be summarized and included in the CAPA. Your Director of QA/RA stated that this review was not conducted.
c) CAPA #013-2011 identified mislabeled PGA Swage sutures as PGLA Swage sutures due to duplicate part numbers. The CAPA did not document a requirement for verification of the corrective action.
We have reviewed your response and have concluded that the adequacy cannot be determined at this time. For CAPA #017-2011, you stated in NCR#011-2013 that documents lacking in the file provided to our investigator upon his request for complete files, had been found and included verification of effectiveness of the CAPA. For CAPA #013-2011, you stated in your response that an Effectiveness Evaluation was conducted. These additional documents were not included with your response.
2. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example, your Complaint Handling Procedure, 820.198, effective August 16, 2012, does not require communications alleging deficiencies related to identity, quality, durability, reliability, safety, effectiveness, or performance of the MedLEDTM line of headlamps be handled as a complaint unless the device is under warranty. The intended use of MedLEDTM devices is to provide light during surgical procedures. Our investigator reviewed five Returned Goods Authorizations for MedLEDTM devices in which he observed 17 device issues, such as exposed battery pack wiring and wiring shorts, which were not identified or handled as complaints. Additionally, you did not record the complainant contact information or evaluation of MDR reportability as required by the regulations.
We have reviewed your response and concluded that it was inadequate because your Complaint Handling procedure 820.198 included in your response states that MedLEDTM units returned after the warranty period are not considered to be verified complaints. Your procedure does not require MedLEDTM devices thatwere returned for alleged deficiencies related to identity, quality, durability, reliability, safety, effectiveness, or performance to be handled as complaints.
Your response states that the MedLEDTM lifetime/warranty period is 1-year. In the MedLEDTM Product Catalog collected during the inspection, the MedLEDTM is described as “having long life with excellent durability.” Your response is inadequate because you did not include documentation of the expected life of the MedLEDTM product line to justify not handling MedLEDTM products returned outside the warranty period as complaints. You did not provide labeling in your response that addresses the expected lifetime of the MedLEDTM product line.
3. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).
For example, you changed the specifications for the (b)(4) applicator needle sheath, product 1200-1820-25, to reduce the likelihood of sterile barrier breach but did not document validation or verification of the new needle sheath.
We have reviewed your response and have concluded that the adequacy cannot be determined at this time because you did not provide documentation of the design change including verification or validation.
4. Failure to establish procedures to validate processes whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a).
For example, your Test Protocol, VP-01B-TR, Needle Packaging Validation, effective 08/12/10 states under section 5.3, Acceptance Criteria, that RP Cutting Needle packaging is considered acceptable for use if all samples pass the (b)(4) testing. Six of (b)(4) aged samples failed the (b)(4) test yet you concluded that the packaging configuration currently used for the RP Cutting Needle is effective to perform as intended for the shelf-life of the product.
We have reviewed your response and find it inadequate. We acknowledge that you performed a revalidation; however, you should also provide your plan to prevent such significant errors from recurring during validation activities.
5. Failure to adequately establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a).
For example, you include a requirement to trend CAPA data in Management Review per the procedure Corrective Actions, 820.100 but have no procedures for how the data is to be trended and how trends are defined.
We reviewed your response and have concluded that it was inadequate because you failed to include the new trending SOP which you identified in NCR#014-2013.
Our inspection also revealed that your firm’s VILET™ sutures, V423 dyed suture is misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that you failed 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 CFR 806-Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limit to, the following:
Failure to submit a written report to FDA of any correction or removal of a device initiated to remedy a violation of the act caused by the device which may present a risk to health, within 10-working days of initiating such correction or removal, as required by 21 CFR Part 806.10(a)(2) and 806.10(b).
For example, you failed to submit a written report to FDA for the correction or removal of VILET sutures, V423, which were mislabeled as undyed. You sent an “Urgent: Medical Device Recall” letter to customers informing them that there was “a labeling discrepancy resulting in violet-colored sutures being labeled as undyed”; and asking them to quarantine and return the affected product to Riverpoint Medical. The letter also stated that replacements would be provided.
Please note the definition of “Risk to health” in 21 CFR 806.2(j)(2) means that use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote. If the suture was to be used in plastic surgery, especially in a subcuticular usage, and especially on the face or other visibly sensitive tissues, it would have significantcosmetic defect. Specifically, this is a temporary or medically reversible adverse health consequence and the risk of a serious adverse health consequence is remote.
A follow-up inspection will be required to assure that corrections and/or corrective actions are adequate.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, 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 awarding of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as 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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: U.S. Food and Drug Administration Seattle District Office, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. Refer to the WL SEA 13-19 when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer Lori J. Silverstein at 425-302-0470.
Finally, you 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.
Charles M. Breen