- Delivery Method:
- United Parcel Service
- Medical Devices
Recipient NameJohn T. Bauer
- Centurion Medical Products Corporation
100 Centurion Way
Williamston, MI 48895-9086
- Issuing Office:
- Division of Medical Device and Radiological Health Operations East
CMS # 598837
June 11, 2020
Dear Mr. Bauer:
The United States Food and Drug Administration (FDA) conducted inspections of Centurion Medical Products Corporation’s medical device operations located at 301 Catrell Drive, Howell, MI from August 5 through 20, 2019, and at 100 Centurion Way, Williamston, MI from October 21 through November 1, 2019. During these inspections, a FDA investigator determined that your firm is a manufacturer of sterile convenience kits, such as the Vascular Access Bundle (CVI3505), Perm Cath Removal Kit (MNS8275), and Ultimate Line Tray (ULT2175A) (together, Convenience Kits). The inspections revealed that the Convenience Kits contain two or more devices and at least one drug co-packaged together. Generally, the Convenience Kits are intended for use during a variety of vascular and other medical procedures. For example, the Vascular Access Bundle Convenience Kit appears to be intended to assist in enabling venous access via, for example, an intravenous (IV) line and includes, but is not limited to: a scalpel, a needle, and lidocaine. The scalpel and needle are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(h)) and the lidocaine is a drug as defined by section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(g)) because the products are intended for use in the cure, mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body. Because the Convenience Kits are comprised of device and drug products packaged together in a single package or as a unit, they are combination products within the meaning of 21 CFR 3.2(e)(2). As further explained below, the Convenience Kits are being manufactured, marketed, and distributed in violation of the Act.
The Convenience Kits were not approved or cleared by FDA for marketing in the U.S. The appropriate marketing application(s) for a combination product, such as the Convenience Kits, generally depends on which agency component (e.g., Center for Devices and Radiological Health (CDRH)) has the lead responsibility for the premarket review and regulation of the combination product. Based on the inspections at your firm and our analyses of evidence collected during the inspections, it appears that CDRH would have the lead responsibility for the premarket review of the Convenience Kits. Accordingly, your firm’s Convenience Kits are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect for each Convenience Kit 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 Convenience Kits 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 each device 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 FDA [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the devices is described on the Internet at:
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Until your firm submits the appropriate marketing application(s) and receives written notification that it may market the Convenience Kits, your firm may not continue distributing the Convenience Kits. Your firm may obtain a formal determination of the agency component with the lead regulatory responsibility for each Convenience Kit by submitting a Request for Designation (RFD) with the FDA’s Office of Combination Products (OCP). For further information about the RFD process, you may visit OCP’s website at http://www.fda.gov/CombinationProducts/default.htm or contact OCP at 301-796-8930 or email@example.com.
We note that your firm manufactures the Convenience Kits, including, but not necessarily limited to, undertaking design, assembly, relabeling, repacking, and processing activities. Your firm’s November 22, 2019, response to the Form FDA 483, List of Inspectional Observations (Form FDA 483) dated November 1, 2019, and June 4, 2020, “Follow-Up Response to Form FDA 483” state that your firm’s operations are limited to “simply placing lawfully marketed (i.e., 510(k)-cleared or exempt) medical devices together in a kit and sterilizing them.” However, evidence collected during the inspections demonstrates that your firm’s manufacturing operations raise questions about the safety and effectiveness of your Convenience Kits. Specifically, the inspections revealed that, as part of the Convenience Kit manufacturing process, your firm opens and removes the original packaging of the finished device components, including sterile devices, before assembling, repacking, and relabeling the components together in a finished kit. For example, the inspections revealed that your firm removes hypodermic needles from the needles’ sterile barriers; repacks the needles into the kit in an environment that is not adequately controlled; and sterilizes the finished kit. Removal of the needles from their sterile barriers and handling such products in an inadequately controlled environment may significantly affect the safety and effectiveness of the needle and the other finished device components in the Convenience Kits. Specifically, these activities may expose hypodermic needles to bioburden, which can increase the likelihood of patient harm during use, such as infection due to microbial contamination of the needle. Additionally, we remind you that repeated sterilization of finished device components may significantly affect the safety and effectiveness of the Convenience Kits’ finished device components (e.g., speeding material degradation; negatively impacting form, fit, and/or function of the device components).
We also remind you that under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), device labeling must bear adequate directions for the purposes for which they are intended or otherwise meet the requirements for an exemption from section 502(f)(1) of the Act under 21 CFR 801 Subpart D. Failure to include appropriate labeling, including the finished device components’ original labeling, may cause patient harm due to, for example, incorrect or unsafe use or storage of the individual finished device components.
The inspections also revealed that the Convenience Kits 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.
We received your responses dated September 10, 2019, and November 22, 2019, from Karen Kowalczyk, Senior Director, Quality Assurance, concerning our investigator’s observations noted on two separate Forms FDA 483 issued to your firm on August 20, 2019, and November 1, 2019, respectively. We also received your responses dated February 21, 2020, and June 4, 2020, from Ms. Kowalczyk which provided updates for your Williamston facility. We address your responses below.
Your violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example,
- Design input requirements have not been adequately defined, as required by 21 CFR 820.30(c), for your sterile Vascular Access Bundle kit, product code CVI3505 that include sterile, non pyrogenic hypodermic needles (component #BD305921) that are removed from their original packing. During our inspection at your Howell facility, we observed that you performed these operations in an assembly room which is considered a “(b)(4),” and you had not defined allowable limits for nonviable particulates in this area.
- Design input requirements have not been established, as required by 21 CFR 820.30(c), for sterile kits that include surgical gowns (finished device component #SGL130) that do not have an expiration date. During our inspections, we observed that you label kits with an expiration date, but do not assess the performance shelf life for devices within the kit to ensure they perform as intended throughout your labeled shelf life.
We reviewed your firm’s responses and concluded that the corrective actions described in the responses are inadequate to address the above design violation. Specifically, you have not provided adequate detail to ensure your proposed corrections will be sufficient to address the systemic quality problems observed at your facilities.
2. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example, during our inspection at your Williamston facility, we observed:
- CAPA 15-008 was opened on November 20, 2015, due to complaints of occlusions in (b)(4) and (b)(4) catheters supplied by (b)(4). Your corrective action was to perform a 100% inspection for incoming catheters, and the CAPA was closed on August 7, 2018. During the inspection, we observed that your firm continues to receive complaints of occlusions, yet you have not revisited the effectiveness of the closed CAPA.
- CAPA 0012-19 was opened on August 21, 2019, as a result of FDA 483 observation #1 of the Howell FDA inspection. This observation addressed the lack of environmental controls in your facility’s (b)(4) where sterile devices such as hypodermic needles, were being removed from original packaging and placed in kits. This CAPA addressed the Howell facility but did not take into account your other facilities where similar manufacturing activities occur.
We reviewed your firm’s responses and understand that you have completed corrective actions to address the two observations noted above. We will need to verify during a reinspection that your revisions to your current procedures are being implemented properly and are adequate to address the above violation.
3. Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 CFR 820.50(a)(1). For example, your firm has not adequately defined purchasing requirements for various catheters that are purchased from (b)(4). Your quality agreement with this supplier requires the supplier to comply with 21 CFR Part 820 and establish procedures for process validation. However, during the inspection of theWilliamston facility we observed that the (b)(4) bonding process used by your supplier to assemble (b)(4) had not been adequately validated.
We reviewed your firm’s responses and understand that you have completed corrective actions related to the specific example described above. For example, you have recently completed validation of the bonding for the (b)(4) purchased from (b)(4). We will need to verify during a reinspection that your current purchasing control system is effective in ensuring that all purchased or otherwise received product and services conform to specified requirements.
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. 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.
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.
We are available for a meeting to discuss the above violations and their statuses as well as any additional corrective actions you plan to take in response to this Warning Letter. This meeting will also allow you to ask any questions you may have concerning design control. Please contact Compliance Officer, Karen Archdeacon at 781-587-7491 or at firstname.lastname@example.org if you are interested in scheduling a meeting.
If you have questions regarding any issues in this letter, please contact Compliance Officer, Karen Archdeacon at 781-587-7491 or at email@example.com. Please send your reply electronically to Gina Brackett, Director of Compliance Branch, 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 Form FDA 483s issued at the close of the inspections 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.
Binita Ashar, M.D., M.B.A., F.A.C.S.
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Joseph Matrisciano, Jr.
Program Division Director
Office of Medical Device and Radiological Health
Cc: Mr. Charlie Mills, CEO
Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093