SnugZ/USA, LLC
Form 483 issued November 30, 2018 · West Jordan, Utah
- Inspection
- Nov 26 – Nov 30, 2018
- Investigator
- Nicholas L. Hunt
- Observations
- 14
- Pages
- 10
- FEI number
- 3009188709
In short: On November 30, 2018, FDA issued a Form 483 with 14 observations to SnugZ/USA, LLC in West Jordan, Utah (FEI 3009188709) after an inspection that ran Nov 26 – Nov 30, 2018. The investigator was Nicholas L. Hunt. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 9 of 14 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability program for drug products does not include meaningful…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 04
You did not retain reserve samples for drug products for (b) (4) dates…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmSnugZ/USA, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SnugZ/USA, LLC?
FDA listed 14 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected SnugZ/USA, LLC?
Nicholas L. Hunt is named on this Form 483, for the inspection of Nov 26 – Nov 30, 2018. Each investigator has a profile showing what they cite most.
When was SnugZ/USA, LLC inspected by FDA?
The inspection ran Nov 26 – Nov 30, 2018, and the Form 483 is dated November 30, 2018.
How do I get the full Form 483 for SnugZ/USA, 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.