Nutrix International, LLC
Form 483 issued April 11, 2019 · Salt Lake City, Utah
- Investigator
- Roger F. Zabinski
- Observations
- 4
- Pages
- 4
- FEI number
- 3014245821
In short: On April 11, 2019, FDA issued a Form 483 with 4 observations to Nutrix International, LLC in Salt Lake City, Utah (FEI 3014245821). The investigator was Roger F. Zabinski. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
- 03
The separate or defined areas and control systems necessary to prevent contamination…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmNutrix International, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nutrix International, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls 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 Nutrix International, LLC?
Roger F. Zabinski is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Nutrix International, LLC inspected by FDA?
This Form 483 is dated April 11, 2019.
How do I get the full Form 483 for Nutrix International, 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.