Dignity Health- Northridge Hospital Medical Center
Form 483 issued December 1, 2017 · Northridge, California
- Inspection
- Oct 23 – Nov 7, 2017
- Investigators
- Andrew K. Haack· Uttaniti Limchumroon
- Observations
- 10
- Pages
- 6
- FEI number
- 2074359
In short: On December 1, 2017, 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 Oct 23 – Nov 7, 2017. The investigators were Andrew K. Haack and 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.
Most cited: 21 CFR 211.42 (5×) · 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your facility design allowed the influx of poor quality air into…
- 02
Sinks or drains were present in the cleanroom where the ISO 5 classified aseptic…
- 03
The ISO 5 classified aseptic processing area was located within a non-classified…
- 04
Unsealed, loose ceiling tiles were…
This inspection in context
Andrew K. Haack
12 documents · 2017–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
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
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 and production. 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?
Andrew K. Haack and Uttaniti Limchumroon are named on this Form 483, for the inspection of Oct 23 – Nov 7, 2017. Each investigator has a profile showing what they cite most.
When was Dignity Health- Northridge Hospital Medical Center inspected by FDA?
The inspection ran Oct 23 – Nov 7, 2017, and the Form 483 is dated December 1, 2017.
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.