UMass Memorial Medical Center
Form 483 issued December 11, 2015 · Worcester, Massachusetts
- Inspection
- Dec 9 – Dec 11, 2015
- Investigators
- Jeffrey J. Thibodeau· Sherry K. Markwell
- Observations
- 3
- Pages
- 3
- FEI number
- 3004123934
In short: On December 11, 2015, FDA issued a Form 483 with 3 observations to UMass Memorial Medical Center in Worcester, Massachusetts (FEI 3004123934) after an inspection that ran Dec 9 – Dec 11, 2015. The investigators were Jeffrey J. Thibodeau and Sherry K. Markwell. Most observations concern cAPA.
At a glance
3 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written MDR Procedure does not include an internal system which provides for the timely and…
- 02
MDR event files have not…
- 03
The user facility did not submit FDA Form 3500A or electronic equivalent to the known device…
This inspection in context
Jeffrey J. Thibodeau
7 documents · 2015–2024
Cites 820.70(b) (production and process controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmUMass Memorial Medical Center history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at UMass Memorial Medical Center?
FDA listed 3 observations on this Form 483, mostly about cAPA. The opening words of each observation are shown on this page.
Who inspected UMass Memorial Medical Center?
Jeffrey J. Thibodeau and Sherry K. Markwell are named on this Form 483, for the inspection of Dec 9 – Dec 11, 2015. Each investigator has a profile showing what they cite most.
When was UMass Memorial Medical Center inspected by FDA?
The inspection ran Dec 9 – Dec 11, 2015, and the Form 483 is dated December 11, 2015.
How do I get the full Form 483 for UMass Memorial Medical Center?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.