General Hospital Corporation
Form 483 issued December 18, 2015 · Boston, Massachusetts
- Inspection
- Dec 15 – Dec 18, 2015
- Investigators
- Elizabeth B. Griffin· Sherry K. Markwell
- Observations
- 4
- Pages
- 4
- FEI number
- 1283713
In short: On December 18, 2015, FDA issued a Form 483 with 4 observations to General Hospital Corporation in Boston, Massachusetts (FEI 1283713) after an inspection that ran Dec 15 – Dec 18, 2015. The investigators were Elizabeth B. Griffin and Sherry K. Markwell. 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
Written MDR procedures have not been developed and maintained…
- 02
The user facility did not submit FDA Form 3500A or electronic equivalent to FDA within ten…
- 03
The user facility did not submit FDA Fon n 3500A or electronic equivalent to the FDA…
- 04
MDR event files do not contain or reference all adverse event information in the possession of…
This inspection in context
Elizabeth B. Griffin
1 document · 2015
Cites 803.30(a)(1) (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 firmGeneral Hospital Corporation 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 General Hospital Corporation?
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 General Hospital Corporation?
Elizabeth B. Griffin and Sherry K. Markwell are named on this Form 483, for the inspection of Dec 15 – Dec 18, 2015. Each investigator has a profile showing what they cite most.
When was General Hospital Corporation inspected by FDA?
The inspection ran Dec 15 – Dec 18, 2015, and the Form 483 is dated December 18, 2015.
How do I get the full Form 483 for General Hospital Corporation?
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.