Dignity Health- Northridge Hospital Medical Center
Form 483 issued March 11, 2016 · Northridge, California
- Inspection
- Feb 16 – Mar 11, 2016
- Investigator
- Uttaniti Limchumroon
- Observations
- 10
- Pages
- 7
- FEI number
- 2074359
In short: On March 11, 2016, FDA issued a Form 483 with 10 observations to Dignity Health- Northridge Hospital Medical Center in Northridge, California (FEI 2074359) after an inspection that ran Feb 16 – Mar 11, 2016. The investigator was Uttaniti Limchumroon. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
6 of 10 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 04
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
This inspection in context
Uttaniti Limchumroon
20 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmDignity Health- Northridge Hospital Medical Center history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dignity Health- Northridge Hospital Medical Center?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Dignity Health- Northridge Hospital Medical Center?
Uttaniti Limchumroon is named on this Form 483, for the inspection of Feb 16 – Mar 11, 2016. Each investigator has a profile showing what they cite most.
When was Dignity Health- Northridge Hospital Medical Center inspected by FDA?
The inspection ran Feb 16 – Mar 11, 2016, and the Form 483 is dated March 11, 2016.
How do I get the full Form 483 for Dignity Health- Northridge Hospital 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.