NATURE'S FUSIONS, LLC
Form 483 issued January 21, 2025 · Orem, Utah
- Inspection
- Jan 15 – Jan 21, 2025
- Investigator
- Carolina D. Vasquez
- Observations
- 7
- Pages
- 6
- FEI number
- 3012853845
In short: On January 21, 2025, FDA issued a Form 483 with 7 observations to NATURE'S FUSIONS, LLC in Orem, Utah (FEI 3012853845) after an inspection that ran Jan 15 – Jan 21, 2025. The investigator was Carolina D. Vasquez. Most observations concern quality system and materials.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 04
Written procedures are not established for evaluations done at least annually and including provisions for a…
This inspection in context
Carolina D. Vasquez
9 documents · 2022–2026
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in California.
The firmNATURE'S FUSIONS, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.137(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NATURE'S FUSIONS, LLC?
FDA listed 7 observations on this Form 483, mostly about quality system, materials and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected NATURE'S FUSIONS, LLC?
Carolina D. Vasquez is named on this Form 483, for the inspection of Jan 15 – Jan 21, 2025. Each investigator has a profile showing what they cite most.
When was NATURE'S FUSIONS, LLC inspected by FDA?
The inspection ran Jan 15 – Jan 21, 2025, and the Form 483 is dated January 21, 2025.
How do I get the full Form 483 for NATURE'S FUSIONS, 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.