University of Massachusetts Memorial Medical Ctr.

Company: University of Massachusetts Memorial Medical Center.
Product: Blood products
Date: 9/12/02

In no more than fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps you have taken to correct these violations and to prevent them from recurring. Your response should also indicate the status of the modifications you have requested to the Meditech software program you are using, advise us as to the hiring status of the new Quality Assurance/Compliance Specialist and describe that employee’s proposed duties, provide copies of your revised SOPs and your plan for implementing these procedures to assure that all personnel are familiar with them. In addition, please provide assurances that adequate standard operating procedures exist for all of your blood banking operations. Your response should also include examples of documentation showing that corrections have been achieved. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time period within which corrections will be completed. Failure to correct these violations promptly could result in further action being taken by FDA, including seizure and/or injunction.

FDA District: New England District Office

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.

Latest News!

Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.  Contact

Corporate Office

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