From staffing of public Centurion has over 9,000 employees coast to coast. Our dedication to making a difference and our passionate team of the best and the brightest healthcare employees has made us one of the leaders of the correctional health industry.
2004 Apr [cited 2015 Jan];86-A(4);864-7. Centurion sets the standard. While our public service settings vary among correctional facilities, state hospitals, Centurion Medical Products 301 Catrell Dr Howell MI 48843. We provide malpractice insurance for all providers and clinicians. Whether to keep your skill set on the leading edge, meeting your licensing requirements, or propelling your career forward, you can count on us to support you. We also offer a Roth 401(k) post-tax savings option to further diversify your savings.We recognize that having a healthy work-life balance is valuable to our employees. We offer company-paid time off and holidays to employees after they have completed their first 90 days of continuous employment.We are proud of our unparalleled commitment to your personal and professional growth.
§ 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. 1 review of Centurion Medical "BE VERY CAREFUL with what they say they will charge you! We also offer specialty medical and behavioral health services to other healthcare settings in the community. Get directions, reviews and information for Centurion Medical Products in Howell, MI. medical and behavioral health programs to full management of complex, multi-site 215 Chicago Medical and Hospital Equipment Timed Auction TIMED AUCTION , 09/11/2020 4:00 PM CDT - 09/17/2020 9:00 AM CDT , Upcoming Sale Lots: 0 As part of our team, you will be able to choose the health plans that best meet your needs.All full-time and part-time employees are eligible to participate in Centurion’s 401(k) Savings Plan immediately. 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. The medical-legal aspects of compartment syndrome. For more than half a century, Centurion products have been transforming the landscape of healthcare right at the point of care. For example, your firm has not adequately defined purchasing requirements for various catheters that are purchased from We reviewed your firm’s responses and understand that you have completed corrective actions related to the specific example described above. Centurion sets the standard. Reviews (517) 552-7600 Website. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. Centurion contracts with state and local governments nationwide to provide comprehensive healthcare services to correctional facilities, state hospitals, and other community settings. 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. Please contact Compliance Officer, Karen Archdeacon at If you have questions regarding any issues in this letter, please contact Compliance Officer, Karen Archdeacon at Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. We also received your responses dated February 21, 2020, and June 4, 2020, from Ms. Kowalczyk which provided updates for your Williamston facility. 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. For further information about the RFD process, you may visit OCP’s website at We note that your firm manufactures the Convenience Kits, including, but not necessarily limited to, undertaking design, assembly, relabeling, repacking, and processing activities. 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. Centurion Medical Products Corporation.
For more than half a century, Centurion products have been transforming the landscape of healthcare right at the point of care. § 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. Learn more about your rights on our 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. 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. The inspections revealed that the Convenience Kits contain two or more devices and at least one drug co-packaged together.