WARNING LETTER
Medline Industries, LP
MARCS-CMS 677545 —
March 18, 2024
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
James Boyle
Recipient Title
CEO
Medline Industries, LP
3 Lakes Drive
Northfield
,
IL
60093-2753
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Secondary Issuing Offices
United States
WARNING LETTER
CMS# (677545)
March 18, 2024
Dear Mr. Boyle:
During an inspection of your firm located at 3 Lakes Drive, Northfield, IL on December 11, 2023, through January 22, 2024, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer and complaint file establishment of sterile and bulk non-sterile syringes, needles for human and veterinary use under the Medline brand, and sterile convenience kits used in operating rooms. 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.
We received a response(s) from Joseph Zeman dated February 12, 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 this response below, in relation to each of the noted violations.
Unapproved Device Violations
Our inspection revealed that the
MEDLINE SYRINGES, MULTIPLE
and the Jiangsu Shenli Medical Production Co. Ltd. Piston syringes of the sizes and configurations listed in
Table 1
, which you include in convenience kits, 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.
Model #
Item Description
Model #
Item Description
83077
SYR 30ML L/S
91839
SYR 20ML L/L YELLOW
83078
SYR 30ML L/L
91840
SYR 3ML L/L PURPLE
83079
SYR 60ML L/S
91841
SYR 5ML L/L PURPLE
83080
SYR 60ML L/L
91842
SYR 10ML L/L PURPLE
83081
SYR 10ML L/S
91845
SYR 20ML L/L BLUE SALINE
83082
SYR 10ML L/L
91846
SYR 10ML L/L YELLOW CONT
83083
SYR 3ML L/S
91847
SYR 10ML L/L BLUE LIDO
83084
SYR 3ML L/L
91849
SYR 10ML L/L BLUE SALINE
83085
SYR 5ML L/S
91850
SYR 10ML L/L RED LIDO
83087
SYR 20ML L/S
91851
SYR 10ML L/L RED HEPARIN
83088
SYR 20ML L/L
91852
SYR 5ML L/L YELLOW NITRO
83089
SYR 1ML TB
91854
SYR 10ML L/L YELLOW LIDO
91820
SYR 3ML L/L RED
91855
SYR 10ML L/L YELLOW HEP/SALINE
91821
SYR 3ML L/L GREEN
91856
SYR 10ML L/L RED CONT
91822
SYR 3ML L/L BLUE
91857
SYR 10ML L/L GREEN CONT
91825
SYR 5ML L/L RED
91858
SYR 20ML L/L WHITE SALINE
91826
SYR 5ML L/L GREEN
91859
SYR 5ML L/L PURPLE NITRO
91827
SYR 5ML L/L BLUE
91863
SYR 20ML L/L YELLOW LIDO
91828
SYR 5ML L/L WHITE
91866
SYR 5ML L/L RED NITRO
91829
SYR 5ML L/L YELLOW
91867
SYR 5ML L/L BLUE HEPARIN
91830
SYR 10ML L/L RED
91872
SYR 10ML L/S BLUE
91831
SYR 10ML L/L GREEN
91873
SYR 10ML L/L WHITE LIDO
91832
SYR 10ML L/L BLUE
91874
SYR 10ML L/S RED
91833
SYR 10ML L/L WHITE
91876
SYR CNTRL 10ML L/L YEL
91834
SYR 10ML L/L YELLOW
91877
SYR CNTRL 10ML L/IL YELLOW LIDO
91835
SYR 20ML L/L RED
91878
SYR CNTRL 10 ML L/L RED
91836
SYR 20ML L/L GREEN
91879
SYR CNTRL 10ML L/L GRN
91837
SYR 20ML L/L BLUE
91880
SYR CNTRL 10ML L/L BLUE
91838
SYR 20ML L/L WHITE
91881
SYR 10ML L/L CONTROL
Table 1.
List of Jiangsu Shenli Medical Production Co. Ltd. Piston syringe configurations implicated in this Warning Letter.
Specifically, during our inspection:
1. The Jiangsu Shenli Medical Production Co. Ltd. Piston Syringe (5cc Luer Lock) was cleared under K103830. The intended use of the Jiangsu Shenli Medical Production Co., Ltd. 5cc luer lock piston syringe is to inject fluids into or withdraw fluids from the body. Based on FDA's evaluation of your firm's activities, there is evidence that your firm is engaged in the distribution of these Jiangsu Shenli syringes for use within the United States, including as part of convenience kits, with substantially different technological characteristics, namely sizes other than 5 mL, luer slip instead of luer lock tips, syringes intended for specific drugs, different colors (i.e., colorants), and control syringes, each of which constitute a significant change or modification in design that could significantly alter the safety or effectiveness of the device. For further explanation on the need for a new premarket notification, or “510(k),” for changes to the intended use or design affecting safety and effectiveness, it is recommended that you consult the guidance document “Deciding When to Submit a 510(k) for a Change to an Existing Device – Guidance for Industry and Food and Drug Administration Staff (fda.gov).” In the guidance at Figure 3 – Flowchart B: Technology, Engineering, and Performance Changes, FDA explains why changes in size, color, specific drug indications and connector type all constitute a major change or modification to the device’s intended use, for which there is not clearance or approval.
As discussed above the products listed in
Table 1
are misbranded because there are one or more change(s) or modification(s) to each device that could significantly affect the safety or effectiveness of the devices you have purchased from the manufacturer, Jiangsu Shenli, despite the manufacturer not submitting a 510(k) to FDA. Specifically, changing the volume of the syringe, switching from a luer lock to a luer slip syringe tip, and changing from a traditional syringe to a control syringe could result in the risk of patient harm such as inaccurate dosing, a leaking device, a higher risk of inappropriate needle detachment, and incorrect device handling. Furthermore, the addition of color additives to the syringe could result in adverse health effects such as allergic reactions, skin irritation or inflammation, pain, fever, red blood cell damage that induces organ stress, and toxicity that leads to loss of organ function or failure. Labeling the syringe for a specific drug can also cause harm because differences in drug viscosities impact the function of the syringe and can result in patient harm such as inaccurate dosing or incorrect drug usage.
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. Further, FDA has observed evidence of postmarket safety signals indicating product quality issues that have the potential to cause serious patient harm. Our inspection revealed multiple customer complaints regarding quality issues (e.g. cracks, breakage during use) for syringes in your surgical kits that include syringes supplied by Jiangsu Shenli Medical Production Co. Ltd that you failed to properly investigate.
Your response dated February 12, 2024, is not adequate. The response indicates you plan to implement further supplier agreements and that you completed a vendor audit for Jiangsu Shenli on February 5, 2024. The findings and outcome of the vendor audit are unclear because you did not provide the complete report. The proposed procedural changes to your vendor evaluation procedure are insufficient because they continue to place all responsibility on the suppliers to claim premarket clearance without you confirming that such clearance exists and is appropriate for device(s) provided by the vendor. It also unclear when these procedures would be implemented and which suppliers they would apply to. Moreover, these procedures would not have detected that K103830 does not permit marketing of syringes other than what was cleared (i.e., 5 mL luer lock syringes). Your response also states you have ceased purchasing syringes from Jiangsu Shenli until they receive appropriate marketing clearance (i.e., a new 510(k)); however, you have not taken action sufficient to mitigate the risks for US consumers related to these violative syringes. For example, you have not committed to recalling and/or removing these violative syringes on the US market, not using any violative syringes already in transit from Jiangsu Shenli to Medline, and not using any violative syringes already received by Medline (e.g., in Mexico for inclusion into Medline convenience kits) but yet to be distributed to US customers. Therefore, the proposed corrections are inadequate.
2. During our inspection, we collected documents used to support changes you made to your 510(k)
MEDLINE SYRINGES, MULTIPLE (K061275)
, such as the Regulatory Assessment of Change (RAC) K061275-03. The RAC K061275-03 document approved Jiangsu Caina Medical Co Ltd (“Jiangsu Caina”) “as an additional contract manufacturer and contract sterilizer” in China for Medline’s 1 mL luer lock and 1 mL luer slip syringes. In your FDA 483 response to Observation 5 from February 12, 2024, you referenced the flowcharts in FDA guidance, “Deciding When to Submit a 510(k) for a Change to an Existing Device” (available at https://www.fda.gov/media/99812/download) for this change. In decision point B5.4 “Do design verification and/or validation activities produce any unexpected issues of safety or effectiveness?”, you indicated “No.” However, review of your RAC K061275-03 documents demonstrates that this decision was incorrect because the testing had unexpected and unexplained failures.
Specifically, you conducted assessments of the Jiangsu Caina 1mL luer lock and luer slip syringes according to ISO 7886-1 in report “L18-215 Final Report” (dated October 3, 2018) titled “Performance Evaluation of Caina SYR101010 1 mL Luer Lock Syringes per ISO 7886-1” and report “L18-216 Final Report” (dated October 3, 2018) titled “Performance Evaluation of Caina SYR101020 1 mL Luer Slip Syringes per ISO 7886-1.” You noted that 55% and 75% of test samples respectively failed when testing the “Tolerance on Graduated Capacity” for delivering 0.2 mL of fluid. You opened an investigation, TOOS18-014, but no further documentation describing the outcome of the investigation was provided. In report “L18-215 – Addendum – 01 Final Report” (dated March 7, 2019) titled “Performance Evaluation of Caina SYR101010 1 mL Luer Lock Syringes per ISO 7886-1”, you stated for the “Tolerance on Graduated Capacity” testing that “the original method did not account for the dead space of the syringe. Therefore, specimens needed to be retested with the correct procedure.” However, “Tolerance on Capacity Testing” per ISO 7886-1:2017 (and as described in section 9.2 of your procedure LAB-00107 Rev. 10) already accounts for dead space, and you still observed a failure rate of 5% among test samples for delivering 0.2 mL of fluid in “L18-215 – Addendum – 01 Final Report” for the 1 mL luer lock syringes. In “MGT - Study Inspection and Status Report”, the “Findings” and “Recommended Actions” sections of each report contain the same handwritten notes saying, “Testing completed as expected” and “None,” respectively, despite seeing failures in the testing. These reports were signed and approved prior to conducting the testing. You then repeated only the “Tolerance on Graduated Capacity” testing in “L21-002 Final Report” (dated January 25, 2021) and reported passing results for all test samples. Your documentation does not contain details of a root cause analysis for the failures observed in the “Tolerance on Graduated Capacity” testing in 2018 and 2019 nor an acceptable rationale for invalidating these test results, whether any changes were made to improve the performance of the syringes between 2019 and 2021 as a result of a root cause analysis, and it does not contain a justification why the testing completed in 2018 and 2019 could be leveraged to support the performance of the syringes tested in 2021. Despite these observations, on January 28, 2021 and January 29, 2021, you finalized RAC K061275-03 document noting, “results from test reports did not produce any unexpected issues of safety or effectiveness.” This statement is incorrect since your performance testing showed unexpected and unexplained failures. Your testing documentation does not support that the modified syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity. The inability of these syringes to deliver the intended dose could lead to administering syringe content in excess of the intended dose and thus lead to harm to patients. Therefore, your change in manufacturing process (i.e., approving Jiangsu Caina as a manufacturer and sterilizer) could significantly affect the safety or effectiveness of the device. Per 21 CFR 807.81(a)(3)(i) a premarket notification was required before introducing the device into commercial distribution.
Quality System Regulation Violations
Our 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 requirements of the Quality System regulation found at 21 CFR Part 820.
These violations include, but are not limited to, the following:
1. Failure to adequately establish and maintain procedures for the identification, documentation, validation, or where appropriate verification, review, and approval of design changes, as required by part 21 CFR 820.30(i). Specifically,
A. Your firm has not adequately implemented “Corporate Design Control Procedure”, SOP-00050, Rev.13 which states:
i. in step 11.3 that “All design changes must be verified and/or validated unless proper justification is given as to why verification or validation is unnecessary.” On or about January 31, 2018, Medline approved a Regulatory Assessment Change (RAC), K061275-01 to allow dimensional changes to the Medline Piston Syringes to improve the user experience by reducing the chance for cracked syringes and plunger pullout. However, your firm’s risk assessment for the dimensional changes to the syringes does not adequately address identified hazards (i.e., cracked syringes or plunger pullout) or support that the changes would mitigate the risk by reducing the probability of the hazard occurring and would not significantly affect the safety or effectiveness of the piston syringes. A user validation was not performed to confirm the dimensional changes did not adversely affect use of the piston syringes. Your firm’s RAC notes that this is not considered a major change and that verification performance/bench testing was sufficient to support your firm’s assessment that a new 510(k) was not required as it did not impact safety and effectiveness of syringes.
ii. in step 6.1 “Design reviews may be held at other times throughout the design and development process, including addressing ambiguous data (e.g., inputs, validation activities etc.)”. For example, the Revised Specifications of piston syringes for K061275, as they relate to Design transfer agreement and current contract manufacturing specifications for the manufacturing of these piston syringes include conflicting or ambiguous dimensional specification requirements. The manufacturing dimensional specifications used by your contract manufacturers do not correspond with dimensional changes approved in Regulatory Assessment Change (RAC), K061275. This may adversely impact product quality based on variations from the approved specification and the current contract manufacturing specifications.
B. You firm was unable to provide our investigators with a completed “Product Change Notice and QA Approval Form” for RAC 061275-01 as required by “Corporate Design Control Procedure”, SOP-00050 step 11.2. According to the procedure, design changes are to be documented on a Product Change Notice and QA Approval Form which are also design control requirements set forth under 21 CFR 820.30(i) and (j). The RAC K061275-01 was initiated for “…dimensional changes to increase the wall thickness, edit the taper of the barrel and the retention ring to improve the user experience by reducing the chance for cracked syringes and plunger pullout.” Your firm did not include an assessment of any new risks as part of the dimensional changes as required by the Product Change Notice and QA Approval Form. In addition, section 11.7.1 of the procedure notes that the Change Verification and Validation section of the Product Change and QA Approval Form should be utilized to determine whether or not verification and/or validation are required for approval of the proposed change(s). The procedure further states “Should verification and/or validation be required, divisional QA must make sure that all supporting documentation, results, justification, etc. are available and attached with form”.
Validation of the design change to support a reduction in cracked syringes and plunger pullout was not performed prior to the implementation and release of product into distribution. In addition, you did not update the design failure mode and effects analysis (DFMEA), SOP-00099-F-00004 and application failures mode and effects analysis (aFMEA) SOP-00099-F-00005 for barrel breakage for the Medline piston syringe (K061275). Your firm continues to receive complaints related to cracked syringes or plunger issues in addition to leaks and breakage during use.
The adequacy of your firm’s response dated February 12, 2024, cannot be determined at this time. The response notes that you have undertaken corrective actions to address the issue with Design Control procedures (design change, design transfer, design change forms), design change form to support the K061275-01 design change and perform an evaluation of design changes to K061275 syringes. These actions encompass conducting a retrospective review of design changes of non-syringe design history files to assure no similar deficiencies exist, updating risk management files, revising procedures, and training staff members. Additionally, corrective actions are being created within the CAPA system for each respective observation to decide if further remediation actions are necessary. However, the response does not furnish specific information regarding the results or outcomes of these corrective actions as they are still ongoing.
2. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, the “Complaint Handling and Evaluation” procedure, CHP-00001 has not been adequately implemented to ensure:
A. Complaints are evaluated to determine whether they are events that are required to be reported to FDA. For example,
i. the complaint handling procedure states that a regulatory investigation is required for Medline labeled or branded product complaints that occur during patient use and/or cause an adverse reaction or injury. Our investigator noted 16 of 20 complaints did not have a regulatory investigation as required:
Complaint Number
Notification Date
Complaint Description
200391920
06/24/2020
Shattered syringe, piece almost went into surgeon’s hand
200430173
02/23/2021
Syringe broke off inside stent connector
200439795
04/21/2021
91881 syringe broke when surgeon started to push in medication; ring on plunger broke off, small plastic piece broke off; very sharp piece and if it went into the abdomen, it would not be found by x-ray. Very dangerous; other syringes have broken, too.
200446540
06/04/2021
Syringes crack and squirt fluids in the CCL during procedures; one exploded with blood in it.
200477084
01/12/2022
Particles found in packaging…can ruin patient’s one chance at treatment
200558997
05/16/2023
Syringes broke during use
200546695
03/03/2023 / [02/15/2023 email sent by customer]
91881C seems very cheap, breaking or not working when trying to use
200441924
05/04/2021
Syringes cracked, medicine going everywhere
200438138
04/09/2021
Surgery has found syringes leaking during use
200392513
06/26/2020
Tabs have been breaking off causing surgeon’s gloves to tear
200488141
03/22/2022
Needles not locking with syringe and leaking Botox out
200507995
07/18/2022
Particles found in syringe
200530846
11/28/2022
Syringe cracked down the middle when using.
200546698
02/08/2023
Control syringe is unsafe and comes apart.
200550282
03/27/2023
“We have been having issues with these syringes. The needle is not well attached and as we draw up sedation with it, we have been losing the sedation and having to waste the meds. It is possible to have the needle on tight so that it does not have to be checked every time. It could also lead to a needle stick if not careful.”
200361247
01/03/2020
[customer] found a hair wrapped around the Syringe Control 10ML product inside this pack.
ii. complaint handling procedure Step 5.4.2 states that “…various “key words” and phrases are used to help determine if complaint is a potentially reportable event. The procedure provides key words and phrases that include but are not limited to… Bleeding, Broken components used on a patient, Cut, Exploded, Needle stick, Severe reaction (requiring a medical intervention), Surgery…”. However, 13 of 16 complaints reviewed by our investigator included these key words or phrases and were not evaluated to determine whether the event was reportable to the FDA.
iii. complaints of medical device malfunctions which if they were to recur would likely cause or contribute to a death or serious injury are not evaluated to determine if such event are required to be reported to FDA as a medical device report as required by 21 CFR 820.198(a)(3). In cases where you specified that a clinical review was not required an adequate justification for not performing was included.
B. All complaints are reviewed and evaluated to determine if investigation is necessary and complaints not needing an investigation shall be maintained with the reason for no investigation along with the name of the individual responsible for the decision.
i. There is no written procedure to define the coding that is selected by the complaint handling personnel. Inaccurate coding of the failure or defect will affect the quality data source analysis and may prevent action(s) being taken when necessary.
a. 15 of 20 complaints reviewed by our investigator during the inspection were incorrectly coded as needle defects or parts/components instead of syringe.
b. Complaints listing multiple failed units are counted as one complaint, for trending and analysis.
c. The procedure is lacking other common key words to help determine reportability such as
Cracks
Dislodgement of the needle from the syringe
Contamination
Particulates
Out of specification syringes (markings dead space, not fitting, deformation)
Leaks
Blockage, foreign material stuck in the syringe.
ii. Our investigator noted that 16 of 20 complaints reviewed for syringe malfunctions or failures complaints were not evaluated or investigated in accordance with your firm’s written procedure “Finished Device Alleged Failure Investigation”, SOP-00031. According to step 3.2.1.3, the following methods are to be used when completing complaint investigations:
a. DHR reviews
b. Review of product change notifications
c. Label and or instructions for use review to ensure necessary instructions/complications are complete.
d. Review of inspection reports
e. BOM review
Finished Device Alleged Failure Investigation Procedure SOP-00031 Rev. 21 (the version reviewed during the inspection) required that: “During the complaint investigation process, any/all applicable investigation methods listed above should be used until the complaint is confirmed.” The result of the investigation methods should be documented within the complaint. If none of the methods can be utilized, a justification/rationale shall be documented in the investigation. A detailed conclusion must be provided.
The adequacy of your firm’s response dated February 12, 2024, cannot be determined at this time. The response notes that your firm has undertaken corrective actions to address the issue of complaint handling, MDR evaluation and determination, complaint coding, and investigations. These actions encompass conducting a retrospective review of complaints (syringe and non-syringe), revising procedures, and training staff members. Additionally, corrective actions are being created within the CAPA system for each respective observation to decide if further remediation actions are necessary. Your firm’s response does not address the multiple complaints contained within each complaint as this can adversely affect their trending and analysis. Further, the response does not furnish specific information regarding the results or outcomes of these corrective actions as they are still ongoing.
3. Failure to adequately establish and maintain procedures for implementing corrective and preventative actions, as required by part 21 CFR 820.100.
Specifically, your firm has not adequately implemented your written procedure “Internal Corrective-Preventive Action Procedure”, SOP-00022, to analyze quality data such as customer complaints in order to identify existing and potential causes of nonconforming product or other quality problems in order to correct and prevent their recurrence. A review of quality data by our investigator noted approximately 2300 syringe complaints between 2020 and 2023 that were either confirmed or not confirmed, for all syringe types (e.g., bulb syringes, feeding syringes, flush syringes, piston syringes etc.) and other OEM syringes. Your firm’s procedure states in step 5.2, that Medline assesses “…quality data on an on-going basis from both a risk and systemic standpoint using appropriate statistical methodology and analysis.” No trend has been identified for piston syringes by defect group/failure code as defined by your firm for any of the following:
Defect Group
Number of Complaints
Needles
122
Particulate/Contamination/Stains/Spots
148
Parts and Components Issues
333
Syringe/Syringe Damaged
129
Assembly Issue
225
Short Text for Cause Code
MFG: Environmental controls
127
MFG: Assembly/Human Error
213
Customer: Knowledge (Use Error)
71
In addition, your firm’s procedure states in section 5.3 that “there may be a scenario where it is appropriate to initiate a CAPA based on one quality event (e.g. one complaint, one MDR, one recall, one external audit observation, etc.) …. decisions should be commensurate with risk, including the extent of action required to address the quality event.”. Your firm’s management stated that there has not been one quality event in the three years of data reviewed for piston syringes that has resulted in CAPA.
During the inspection our investigator noted that you initiated a Regulatory Assessment Change (RAC), K061275-01 to allow dimensional changes to the Medline Piston Syringes to improve the user experience by reducing the chance for cracked syringes and plunger pullout. Your firm’s management explained to our investigator that the RAC was an improvement and enhancement and not done to improve clinical outcomes, mitigate a known risk, or in response to an adverse event. Your firm’s design failure mode and effects analysis (DFMEA), SOP-00099-F-00004 for Medline piston syringe (K061275) lists among other things, piston syringes dimensions and fit as having an impact on product quality and functionality.
The DFMEA indicates that performance testing and finished product testing have reduced the risk as low as possible however your firm continues to receive complaints for loss of primary function among others. All complaints cannot be attributed to application user failures described in your firm’s application failure mode and effects analysis (aFMEA) SOP-00099-F-00005 for Medline piston syringe (K061275).
The adequacy of your firm’s response dated February 12, 2024, cannot be determined at this time. The response notes that your firm has undertaken corrective actions to address the issue with CAPA procedures. These actions encompass conducting a retrospective review of complaints, a reanalysis of complaints, revising procedures, and training staff members. Additionally, corrective actions are being created within the CAPA system for each respective observation to decide if further remediation actions are necessary. However, the response does not furnish specific information regarding the results or outcomes of these corrective actions as they are still ongoing.
4. Failure to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
Specifically, your firm’s Vendor Evaluation Procedure SOP-00003 has not been adequately established or maintained to ensure requirements, including quality requirements have been met by suppliers and contractors. For example, the Vendor Evaluation - Supplier Disposition Form for supplier “S” lacks a documented review of marketing clearance for products you distribute and/or further manufacture. There is no objective evidence to support the quality agreement requirement “Supplier shall only supply product to Medline that has the appropriate marketing clearance.”
The adequacy of your firm’s response dated February 12, 2024, cannot be determined at this time. The response notes that your firm has undertaken corrective actions to address the issue with purchasing controls to include revisions to purchasing control procedures, employee training, retrospective review of all Medline-branded syringes and syringe kit components, performing a review of active Medline-branded medical devices (non-syringes) and submitting a new 510(k) Premarket Notification for all sizes/models of Medline Piston Syringes. Additionally, corrective actions are being created within the CAPA system for the observation to decide if further remediation actions are necessary. However, the response does not furnish specific information regarding the results or outcomes of these corrective actions as they are still ongoing.
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 # 677545 when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer, Rafael Padilla at 312-596-4212 or Rafael.padilla@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,
/S/
Blake Bevill
Program Division Director
Office of Medial Device and Radiological Health
Operations (OMDRHO) Division 2 Central
And
Kellie B. Kelm, Ph.D.
Acting Director
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
03/19/2024
Regulated Product(s)
Medical Devices