Pacific Consolidated Industries LLC
Form 483 issued March 24, 2016 · Riverside, California
- Inspection
- Feb 29 – Mar 24, 2016
- Investigator
- Sonya L. Karsik
- Observations
- 2
- Pages
- 3
- FEI number
- 3002768081
In short: On March 24, 2016, FDA issued a Form 483 with 2 observations to Pacific Consolidated Industries LLC in Riverside, California (FEI 3002768081) after an inspection that ran Feb 29 – Mar 24, 2016. The investigator was Sonya L. Karsik. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
Observations span 1 system, led by capa.
Most cited: 21 CFR 820.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results have…
- 02
: Not…
This inspection in context
Sonya L. Karsik
9 documents · 2009–2019
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmPacific Consolidated Industries LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pacific Consolidated Industries LLC?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Pacific Consolidated Industries LLC?
Sonya L. Karsik is named on this Form 483, for the inspection of Feb 29 – Mar 24, 2016. Each investigator has a profile showing what they cite most.
When was Pacific Consolidated Industries LLC inspected by FDA?
The inspection ran Feb 29 – Mar 24, 2016, and the Form 483 is dated March 24, 2016.
How do I get the full Form 483 for Pacific Consolidated Industries LLC?
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.