Cedars-Sinai Medical Center
Form 483 issued December 7, 2015 · Los Angeles, California
- Inspection
- Dec 1 – Dec 7, 2015
- Investigator
- James R. Fleckenstein
- Observations
- 2
- Pages
- 1
- FEI number
- 3000717534
In short: On December 7, 2015, FDA issued a Form 483 with 2 observations to Cedars-Sinai Medical Center in Los Angeles, California (FEI 3000717534) after an inspection that ran Dec 1 – Dec 7, 2015. The investigator was James R. Fleckenstein. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 803.17 (1×) · 803.30 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written MDR procedures have…
- 02
The user facility did not submit FDA Form 3500A or electronic equivalent to the known device…
This inspection in context
James R. Fleckenstein
1 document · 2015
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in California.
The firmCedars-Sinai 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 Cedars-Sinai Medical Center?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?). The opening words of each observation are shown on this page.
Who inspected Cedars-Sinai Medical Center?
James R. Fleckenstein is named on this Form 483, for the inspection of Dec 1 – Dec 7, 2015. Each investigator has a profile showing what they cite most.
When was Cedars-Sinai Medical Center inspected by FDA?
The inspection ran Dec 1 – Dec 7, 2015, and the Form 483 is dated December 7, 2015.
How do I get the full Form 483 for Cedars-Sinai 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.