Thrive Health and Wellness, LLC, dba Thrive Health Solutions
Form 483 issued April 3, 2025 · En, Colorado
- Inspection
- Mar 25 – Apr 3, 2025
- Investigator
- Taichun Qin
- Observations
- 6
- Pages
- 4
- FEI number
- 3033176989
In short: On April 3, 2025, FDA issued a Form 483 with 6 observations to Thrive Health and Wellness, LLC, dba Thrive Health Solutions in En, Colorado (FEI 3033176989) after an inspection that ran Mar 25 – Apr 3, 2025. The investigator was Taichun Qin. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 6 observations.
Most cited: 21 CFR 211.42 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Lack of a certified ISO-5 classified…
- 02
Failures to conduct media fills that…
- 03
Production areas have difficult to clean or contain porous, particle generating, or visibly…
- 04
Personnel engaged in aseptic processing were…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmThrive Health and Wellness, LLC, dba Thrive Health Solutions history
All 3 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 Thrive Health and Wellness, LLC, dba Thrive Health Solutions?
FDA listed 6 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 Thrive Health and Wellness, LLC, dba Thrive Health Solutions?
Taichun Qin is named on this Form 483, for the inspection of Mar 25 – Apr 3, 2025. Each investigator has a profile showing what they cite most.
When was Thrive Health and Wellness, LLC, dba Thrive Health Solutions inspected by FDA?
The inspection ran Mar 25 – Apr 3, 2025, and the Form 483 is dated April 3, 2025.
How do I get the full Form 483 for Thrive Health and Wellness, LLC, dba Thrive Health Solutions?
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.