UMass Memorial Medical Center

FDA inspection history in Worcester, Massachusetts, 2015

1
Form 483

Every document, by year

  • Form 483

2015: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2015One Form 483, at Worcester, Massachusetts.

Cited most

Across all UMass Memorial Medical Center observations on file

  • 21 CFR 803.17
    What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
    1
  • 21 CFR 803.18
    What are the requirements for establishing and maintaining MDR files or records that apply to me?
    1
  • 21 CFR 803.30
    If I am a user facility, what reporting requirements apply to me?
    1

The complete UMass Memorial Medical Center file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2015-12-11483 Form 483$99

Investigators on these documents

Jeffrey J. Thibodeau (1)Sherry K. Markwell (1)

FEI number 3004123934 · most recent document Dec 11, 2015

About UMass Memorial Medical Center

How many FDA Form 483s has UMass Memorial Medical Center received?

FDA Intel has 1 Form 483 on file for UMass Memorial Medical Center; the most recent is dated Dec 11, 2015.

When was UMass Memorial Medical Center last inspected by FDA?

The most recent FDA inspection document on file for UMass Memorial Medical Center is a Form 483 dated Dec 11, 2015, for the site in Worcester, Massachusetts.

What did FDA cite at UMass Memorial Medical Center?

The regulations cited most in the observations on file for UMass Memorial Medical Center are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 803.18 (What are the requirements for establishing and maintaining MDR files or records that apply to me?), 1 time; 21 CFR 803.30 (If I am a user facility, what reporting requirements apply to me?), 1 time.