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WARNING LETTER

Cardinal Health MARCS-CMS 679404 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices

Recipient:
Recipient Name
Steve Mason
Recipient Title
President/CEO
Cardinal Health

7000 Dublin Place
Dublin, OH 43017
United States

Issuing Office:
Center for Devices and Radiological Health

United States


WARNING LETTER
CMS# 679404

April 24, 2024

Dear Mr. Mason:

During an inspection of your firm Cardinal Health 200, LLC., located at 3651 Birchwood Dr., Waukegan, Illinois 60085 on December 11-20, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is an importer /own label distributor of the Monoject™ Luer-lock tip syringes, intended to inject fluids into or withdraw fluids from the body, and the Monoject™ Enteral Feeding Syringes, intended for use to deliver fluid, feeding, or medications to a patient’s feeding tube. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), each of 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.

We received responses from you dated January 12, 2024, and April 10, 2024, concerning our investigators observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address these responses below, in relation to the noted violations and any additional responses will be reviewed as part of your warning letter response.

Unapproved Device Violations

1. The United States Food and Drug Administration (FDA) has learned that your firm is marketing convenience kits that include certain piston syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd under K103830. These devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that you need to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that you submit and decide whether the product may be legally marketed.

Specifically, the convenience kits your firm markets in the United States include 3 mL, 10 mL, and 20 mL piston syringes and control syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd under K103830. The only Jiangsu Shenli Medical Production Co. Ltd. Piston Syringe cleared under K103830 is their 5cc Luer Lock, and no other size piston syringes were included under K103830. Based on FDA's evaluation of K103830 and your firm's activities, there is evidence that your firm is engaged in the distribution of Jiangsu Shenli syringes for use within the United States, included as part of convenience kits, with substantially different technological characteristics. In particular, FDA’s evaluation revealed that these kits include Jiangsu Shenli syringes in sizes other than 5 mL and also include control syringes. The inclusion of these syringes whose specifications were not included or otherwise reviewed under the conditions of clearance in K103830, constitutes a significant change or modification in design that could significantly alter the safety or effectiveness of the finished kit product. Specifically, changing the volume of the syringe and changing from a traditional syringe to a control syringe could result in the risk of patient harm such as inaccurate dosing and a leaking device.

Your firm’s failure to ensure the syringes you are including in convenience kits, importing, and commercially distributing in the United States have 510(k) clearance has prevented FDA from evaluating the risks posed by these substantially different technological characteristics or from determining that there is reasonable assurance of the safety and effectiveness of these modified devices such that they may be legally marketed syringes.

Quality System Regulation Violations

This inspection also 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:

1. Failure to adequately establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.

Specifically, our inspection found that your Procedure “QS00015426, Manufacturing Concept Sample Inspection” Rev. 4 employed by your firm to outline product requirements, confirm purchased products have met these requirements, and conduct supplier qualification activities, has not been adequately established. Your firm’s procedure does not require that data to demonstrate product requirements are met is reviewed and evaluated during supplier qualification activities. Per your product requirements document “Needle and Syringe PRD” the product requirements for these devices included, but were not limited to, those in ISO Standard 7886-1:2017 “Sterile hypodermic syringes for single use - Part 1: Syringes for Manual Use”. The ISO Standard 7886-1 relates specifically to the manual use of the syringes and includes product specifications such as limits for acidity and alkalinity, extractable metals, and dimensions. The review of your supplier qualification activities disclosed that specific product requirements required under the standard such as dimensions, limits for acidity and alkalinity, and extractable metals were not established in the product requirements document. Furthermore, no data was received from the supplier and/or evaluated at the time of supplier qualification to ensure that other product requirements included in the PRD document were met. In addition, you were not able to produce data to support the use of your Monoject Syringes for compatible use with infusion pumps. In particular, on September 20, 2023 and December 28, 2023, your firm initiated recalls for the Cardinal Health Monoject sterile Syringe Luer-Lock Tip Soft Packs (1, 3, 6, 12, 20, 35 and 60 mL) and Cardinal Health Monoject sterile Enteral Syringes with ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing that resulted in different product dimensions, which can lead to recognition and compatibility issues when used with syringe pumps, patient-controlled analgesia (PCA) pumps, and enteral syringe feeding pumps.

Your responses dated January 12, 2024, and April 10, 2024, indicated that you have opened CAPA-CRP-03163 (also referenced as CAPA QE-00303) to address this observation and that the process will be revised to demonstrate product requirements are met, reviewed, and evaluated during supplier qualification activities. Your response indicates you will revise and update your procedure QS00015441, Private Brand Procedure, and revise your Technical Guide template adding detail and greater focus on customer needs and clinical requirements. You will perform a product audit prior to initial release to verify requirements are met, validations meet requirements, and product lot testing and release acceptance process are statistically based and meets requirements. You will repurpose and revise your procedure QS00015426, Manufacturing Concept Sample Inspection Process, and revise the Q00014202, Private Brand Supplier Quality Agreement Template. Training will be conducted. In addition, you will conduct a systemic review of in-process and completed Private Brand Conversions, from the past three (3) years.

The adequacy of your firm’s response cannot be determined at this time. FDA acknowledges that your responses to date state that your firm has conducted a variety of updates to its internal processes and associated trainings, including, but not limited to, those related to QS00015441 (Private Brand Technical Procedure), QS00015426 (Manufacturing Concept Sample Review), and QS00014202 (Private Brand Supplier Quality Agreement (SQA) Template). However, your corrective actions have not yet been evaluated for effectiveness. A follow-up inspection will need to verify the implementation and the effectiveness of your planned corrective actions.

In addition, we offer the following comment:

  • During our inspection, FDA determined that your firm was engaged in the self-manufacturing of 3, 6, 20, 35, and 60mL Monoject Standard Luer Lock Syringes based on specifications cleared under K945715. Your firm then switched to overseas manufacturing with Jiangsu Caina Medical Co. Ltd. to produce the same size range of syringes branded as Cardinal Health Monject Syringes and based on specifications cleared under K113091. FDA is aware that your firm’s self-manufactured syringes were validated by infusion pump manufacturers for use with their devices, that as of December 2023 your firm’s syringes were collectively marketed and advertised as compatible for use with infusion pumps, and that since switching to overseas manufacturing there have been increases in reported syringe safety issues regarding syringe/infusion pump compatibility resulting in your firm’s ongoing syringe recalls. Further, during our inspection, you were unable to provide documented rationales, assessments or evaluations during the inspection concerning any impact of pump compatibility claims on regulatory submissions for the Cardinal Health Monoject Syringe product family. You also stated during the inspection that existing procedures at the time failed to ensure that this assessment was conducted and documented. No evidence was produced during the inspection describing evaluation of infusion pump compatibility intended use claims for the Cardinal Health Monoject Syringes by you or Jiangsu Caina Medical Co. Ltd, that you conducted any product testing related to the use of Monoject syringes with infusion pumps, or that you informed infusion pump manufacturers of the specification changes to the 3, 6, 20, 35 and 60 ml Monoject Standard Luer Lock Syringes. FDA acknowledges that your firm has ceased using marketing materials regarding compatibility with infusion pumps, and that your firm has taken several actions to revise and review its internal policies regarding device marketing. However, to date FDA has not received information regarding the effectiveness of these actions or what additional actions your firm is taking or plans to take regarding the use of these syringes with infusion pumps, especially in light of known patient safety risks regarding syringe incompatibility with infusion pumps. Accordingly, we request that you provide to us in writing what actions your firm has taken and plans to take regarding these products with respect to their use with infusion pumps.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter 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.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal 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 addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

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 address 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 any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to: Melissa Michurski, Director of Compliance Branch, at oradevices2firmresponse@fda.hhs.gov. Refer to CMS # 679404 when replying. If you have any questions about the contents of this letter, please contact: Demetria Lueneburg, Compliance Officer at 612-758-7210 or Demetria.Lueneburg@fda.hhs.gov.

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 any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely yours,
/S/
James Hildreth
Acting Program Division Director
Office of Medical Device and Radiological Health Operations (OMDRHO)
Division 2 Central

/S/
Kellie B. Kelm, Ph.D.
Acting Office Director
OHT 3: Office of Gastrorenal, ObGyn, General Hospital, and Urology
Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

 
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