Brigham and Women's Hospital
Form 483 issued December 10, 2015 · Boston, Massachusetts
- Inspection
- Dec 7 – Dec 10, 2015
- Investigators
- Sherry K. Markwell· Stephen C. Smith
- Observations
- 4
- Pages
- 3
- FEI number
- 3012030543
In short: On December 10, 2015, FDA issued a Form 483 with 4 observations to Brigham and Women's Hospital in Boston, Massachusetts (FEI 3012030543) after an inspection that ran Dec 7 – Dec 10, 2015. The investigators were Sherry K. Markwell and Stephen C. Smith. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.30 (if I am a user facility, what reporting requirements apply to me?).
At a glance
4 of 4 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
The user facility did not submit FDA Form 3500A or electronic equivalent to within ten working…
- 02
The user facility did not submit FDA Form 3500A or electronic equivalent to the known device…
- 03
Written MDR procedures have not been developed and…
- 04
MDR event files have not…
This inspection in context
Sherry K. Markwell
4 documents · 2015
Cites 803.30 (if i am a user facility, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in Massachusetts.
The firmBrigham and Women's Hospital history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.30(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Brigham and Women's Hospital?
FDA listed 4 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.30 (if I am a user facility, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Brigham and Women's Hospital?
Sherry K. Markwell and Stephen C. Smith are named on this Form 483, for the inspection of Dec 7 – Dec 10, 2015. Each investigator has a profile showing what they cite most.
When was Brigham and Women's Hospital inspected by FDA?
The inspection ran Dec 7 – Dec 10, 2015, and the Form 483 is dated December 10, 2015.
How do I get the full Form 483 for Brigham and Women's Hospital?
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.