- Delivery Method:
- VIA Electronic Mail
- Medical Devices
Recipient NameGregory J. Bullington
- Magnolia Medical Technologies, Inc.
200 W. Mercer Street, Suite 500
Seattle, WA 98119
- Issuing Office:
- Office of Medical Devices and Radiological Health, Division 3
September 17, 2021
Dear Mr. Bullington:
The United States Food and Drug Administration (FDA) conducted an inspection of your medical device operations at 200 W. Mercer Street, Suite 500, Seattle, WA 98119 from June 3, 2021 through July 15, 2021. During the inspection, an FDA Investigator determined that your firm is a specification developer for the Steripath Gen 2 Blood Collection System (K192247). 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 function of the body.
This inspection revealed that the Steripath Gen 2 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, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received your firm’s response dated August 5, 2021 concerning our Investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued on July 15, 2021. We address the responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example,
a. Your firm’s Corrective and Preventive Action SOP, D00011, Rev. D requires your firm to track all meetings pertaining to your CAPA activities in the product investigation section of your Corrective Action Report (CAR). Your firm’s HHE-001 Closure Memo dated January 13, 2021 references meetings held to discuss CAR C00046 on October 8, 2020 and in November 2020. However, these meetings are not described or attached to your CAR C00046.
We have reviewed your firm’s response dated August 5, 2021 and determined it is inadequate. Your firm’s response acknowledges these meetings were held and states the meeting minutes were never finalized. Your response states your CAPA procedures will be revised to clarify requirements for maintaining meeting minutes. However, your response does not identify that your firm has now finalized and included in your records the subject meeting minutes. Further, your response does not address how your firm evaluated other CARs for similar deficiencies. Lastly, we acknowledge your firm’s commitment to revise your CAPA procedures, however, there is insufficient detail of the proposed changes in your response to allow us to evaluate the adequacy at this time.
b. Your firm’s CAPA C00046 includes an investigation conducted by your supplier of your butterfly retractable needles for premature retraction. This investigation identified three potential causes including 1) (b)(4), 2) application of (b)(4) sterilization, and 3) failure to adhere to shelf-life specifications assigned by the component supplier. Your firm’s CAPA C00046 includes your firm’s evaluation of the primary cause ((b)(4)); however, your firm did not investigate or document your evaluation of the other potential causes.
We have reviewed your response dated August 5, 2021 and determined it is inadequate. Your response states your firm is revising your CAPA procedures. Your response states your firm held several meetings to discuss these causes; however, it does not identify how you have documented and included your evaluations and investigations into these cases in your CAR C00046. Additionally, your response does not address if your firm has reviewed other CARs for similar deficiencies.
Additionally, in your response to this letter, please also include description and records of corrective actions or evaluations conducted into the acceptance activities and purchasing controls associated with your butterfly retractable needles.
c. Your firm initiated CAR C00050 on August 20, 2020 after identifying the bill of materials for product parts (b)(4) (various configurations of your Steripath Gen 2 device) contained incorrect instruction for use (IFU) designations. This CAR was closed on April 29, 2021 stating it did not qualify for a CAR because it was identified prior to implementation of the changes. However, your firm identified in October 2020, two additional lots of product ((b)(4) and (b)(4)) were manufactured and subsequently quarantined and reworked. Additionally, our inspection identified that a third lot, 9448037, was manufactured and distributed using the incorrect IFU that your firm did not identify prior to distribution. Your firm’s CAR C00050 did not include adequate investigation to identify and correct all affected products.
We have reviewed your response dated August 5, 2021 and determined it is inadequate. Your response states your firm is revising your CAPA procedures and has opened CAR C00073 to investigate the CAPA deficiencies. However, there is inadequate description of the proposed changes for us to evaluate the adequacy at this time. Additionally, your response does not address evaluations of other CARs to determine if similar deficiencies exist.
d. Your firm initiated CAR C00055 on January 8, 2021 to investigate lack of implementation of changes to your Steripath Gen 2 labeling after receiving clearance for expanded indications for use. Your CAR C00055 does not include descriptions and records of your investigation into the cause of the nonconformance to ensure systemic corrective actions.
We have reviewed your response dated August 5, 2021 and determined it is inadequate. We acknowledge you have initiated a removal for this product and your response states your firm is revising your CAPA procedures. However, your response does not address what corrective actions you are taking to specifically address CAR C00055. Additionally, your response does not address reviews of other CARs to determine if similar deficiencies exist.
2. Failure to establish and maintain adequate procedures for verifying the device design to confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f).
Specifically, your firm did not conduct verification testing to support the shelf life of your Steripath Gen 2 with the butterfly needle inlet accessory.
We have reviewed your response dated August 5, 2021 and the “Steripath Gen2 Blood Collection Set (Needle) Configuration Shelf Life Verification Report”, D00309, Rev. A dated June 11, 2021. We cannot determine the adequacy of your response at this time. Your firm’s response states your firm will conduct a retrospective review of all verifications of your Steripath Gen 2 device to assess the impact of using the (b)(4) inlet accessory as the model in the testing. Additionally, your response states your firm is updating your design verification procedures to require evaluation of the inlet and outlet accessories. We request you provide updates to these activities in your response to this letter. Additionally, the provided verification report shows sections 2.4.2, 2.4.3, and 2.4.4 of the test protocol were not complete. In your response to this letter, please include an explanation of why these sections were not completed.
3. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a).
Specifically, your firm’s supplier of the butterfly needle inlet of your Steripath Gen 2 device applies a 2-year shelf life to the component. Your firm does not have manufacturing procedures to document and control the remaining shelf life of these components when used in the manufacturing of Steripath Gen 2 finished device which you apply a 2-year shelf life.
We have reviewed your response dated August 5, 2021 and we cannot determine the adequacy of your response at this time. Your response commits to reviewing all components of your Steripath Gen 2 device and establish procedures to monitor and control remaining shelf life at the time of manufacturing the device. In response to this letter please include updates and supporting records of implementation of these corrective actions as they progress.
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 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 award of contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been corrected. Also, should FDA determine that your devices do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. If you believe that your products are not in violation of the Act, please respond to FDA with your reasoning and any supporting information for our consideration.
Additionally, On July 7, 2021, FDA held a conference call with your firm’s Director of Operations and your firm’s Director of Quality and Regulatory to discuss concerns pertaining to your firm’s corrective actions associated with CAR C00046. During this call it was communicated to you that your firm’s CAR C00046 did not document corrective actions to address previously distributed nonconforming products. Your firm’s Director of Operations stated that a timeline of the corrective actions and the investigation addressing these concerns would be provided to the Agency. We have reviewed your firm’s memorandum dated July 12, 2021, and we do not believe the response adequately addresses those concerns. We request a conference call to further discuss your corrective actions to CAR 00046 with our Office of Medical Device and Radiological Health Operations Division 3. Please contact Compliance Officer Jeff R. Wooley to arrange a time for this call.
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 (which must address systemic problems) 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 response should be sent to: US Food and Drug Administration, Division 3/West, Office of Medical Device and Radiological Health Operations at ORADevices3 FirmResponse@fda.hhs.gov. Please identify your response with FEI 3009976527.
If you have any questions about the contents of this letter, please contact Compliance Officer Jeff R. Wooley at 214-253-5251, or via e-mail at firstname.lastname@example.org.
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.
Shari J. Shambaugh
Program Division Director
Office of Medical Devices and Radiological
Health, Division 3