Huntington Memorial Hospital
Form 483 issued December 8, 2015 · Pasadena, California
- Inspection
- Dec 8, 2015
- Investigator
- Janet Pulver
- Observations
- 3
- Pages
- 12
- FEI number
- 2080950
In short: On December 8, 2015, FDA issued a Form 483 with 3 observations to Huntington Memorial Hospital in Pasadena, California (FEI 2080950) after an inspection that ran Dec 8, 2015. The investigator was Janet Pulver. 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
3 of 3 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 FDA and the…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Written MDR procedures have…
This inspection in context
Janet Pulver
10 documents · 2014–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmHuntington Memorial Hospital history
The site's inspection history, in date order.
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 Huntington Memorial Hospital?
FDA listed 3 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 Huntington Memorial Hospital?
Janet Pulver is named on this Form 483, for the inspection of Dec 8, 2015. Each investigator has a profile showing what they cite most.
When was Huntington Memorial Hospital inspected by FDA?
The inspection ran Dec 8, 2015, and the Form 483 is dated December 8, 2015.
How do I get the full Form 483 for Huntington Memorial 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.