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

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.