Warning Letter – Basic design controls violations

June 11, 2020

Interesting excerpts from a warning letter implicating 820.30:

  • “[A]s 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 . . . 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.”
  • “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.”
    • Failure to establish and maintain procedures to control the design of the device: “For example, Design input requirements have not been adequately defined,” and “Design input requirements have not been established, as required by 21 CFR 820.30(c).”
    • Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a).
    • 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. . .”

See the complete Warning Letter regarding Convenience Kits manufactured by Centurion Medical Products Corporation at this link.

Find other interesting warning letters here: https://www.softwarecpr.com/tag/warningletter/

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.