Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) FDA Record
- Latest inspection OAI · Apr 3, 2025
- Last warning letter 2026
Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) has 14 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado), the most recent on Feb 9, 2026. FDA has published 1 Form 483 for Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado).
- Latest recall
- D-0486-2025 · Class II · May 21, 2025
- Latest inspection
- Apr 3, 2025 · OAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 14 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado): FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 1 | 0 | 0 |
| 2025 | 1 | 1 | 0 | 14 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Feb 9, 2026 · Record page |
Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) Form 483s
| Date | Document | FEI |
|---|---|---|
| Apr 3, 2025 · Document on fda.gov | 483 | 3033176989 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0486-2025 | Class II | Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive… | May 21, 2025 |
| D-0478-2025 | Class II | Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88… | May 21, 2025 |
| D-0480-2025 | Class II | Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204… | May 21, 2025 |
| D-0484-2025 | Class II | Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E… | May 21, 2025 |
| D-0485-2025 | Class II | Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88… | May 21, 2025 |
| D-0481-2025 | Class II | Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88… | May 21, 2025 |
| D-0476-2025 | Class II | LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg… | May 21, 2025 |
| D-0482-2025 | Class II | Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E… | May 21, 2025 |
| D-0474-2025 | Class II | Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir… | May 21, 2025 |
| D-0477-2025 | Class II | LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg… | May 21, 2025 |
| D-0475-2025 | Class II | CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E… | May 21, 2025 |
| D-0487-2025 | Class II | Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88… | May 21, 2025 |
| D-0483-2025 | Class II | Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E… | May 21, 2025 |
| D-0479-2025 | Class II | Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite… | May 21, 2025 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 3, 2025 | Englewood, CO | Drugs | Official Action Indicated (OAI) | 3033176989 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado): warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3033176989 | Englewood, CO | 1 | Apr 3, 2025 |
Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) and the FDA: common questions
Has Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado). The most recent is dated Feb 9, 2026.
Has Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) received an FDA Form 483?
FDA has published 1 Form 483 for Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) in its reading room, the most recent dated Apr 3, 2025. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado)?
The most recent FDA inspection on file ended Apr 3, 2025 at Englewood, CO and was classified OAI. FDA has 1 inspection of Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) on file, 1 of them classified OAI (official action indicated).
Has Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) had an FDA recall?
Yes. Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) has 14 FDA recalls on record. The most recent started May 21, 2025.
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