What is an FDA Form 483?

A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.

Does this Form 483 mean Thrive Health and Wellness LLC violated the law?

No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.

What happens after a Form 483 is issued?

The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.

Has Thrive Health and Wellness LLC had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Thrive Health and Wellness LLC so far. Argus ingests new FDA records daily.

FDA Inspects Thrive Health and Wellness LLC: Form 483 with 6 Citations (April 3, 2025)

Key facts

Firm	Thrive Health and Wellness LLC
FEI / inspection ID	3033176989
Inspection end date	April 3, 2025
Citation count	6

Key takeaway: FDA inspected Thrive Health and Wellness LLC in Texas and issued a Form 483 listing 6 inspectional observations following an inspection that concluded 2025-04-03. FDA records classify Thrive Health and Wellness LLC as a producer of sterile and non sterile drug products. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record.

Citations explained

Observation 1 — Lack of a certified 1SO-5 classified area for sterile compounding Specifically, Your

Lack of a certified 1SO-5 classified area for sterile compounding Specifically, Your firm fills syringes intended for subcutaneous injection by withdrawing sterile solution from vials on a benchtop table, located in an unclassified room for the following products: • Semaglutide for .injection • Tirzepatide for injection • Cyanocobalamin for injection • Lipoboost CB-complex) for injection • Sermorelin for injection The dosage of each product varies among patients or across different treatment levels., Your firm produced an average of approximately ·(ijl4f syringes a week. For example, on 3/24/2025, your firm produced approximately lbTT-il1 syringes ofGLP-1 Semaglutide injections: Level 4 (1.7 mg/5mg/rnL), Lot# 03075J, Discard by: 7/7/2025 and GLP-2 Tirzepatide: Level 4 (10 mg /30mg/ml); Lot# 03125A, Discard by: 9/12/2025. These syringes have be1:m dispensed to patients. Additionally, your firm assigned the beyond-use dates (BUDs) or discard-by date to all repackaged syringe products, which are the same as those of the original vials used for filling despite the lack of a certified.

Observation 2 — Failures to conduct media fills that simulate aseptic production operations

Failures to conduct media fills that simulate aseptic production operations. Specifically, The operators involved in repackaging vials into syringe products intended to be sterile have never conducted media fills. For example, on 3/25/2025, it was observed that the operator produced Tirzepatide/ Cyanocobalamin, 15mg/lmg/mL (SrnL), Lot# 03065F, BUD: 7/6/2025; however, the operator has never conducted media fills. Your firm produced approximately ~ syringes a week. {

Observation 3 — Production areas have difficult to clean or contain porous, particle generating, or

Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces. Specifically, Your firm filled the syringes containing products intended to be sterile on a benchtop table in an unclassified ro om that contains potential contaminants, as described below. A. The benchtop table with shelves is cluttered with syringes, containers, utensils, binder clips, wipes, marke1· pens, and other supplies. B. The room also serves as an office, equipped with a computer, chair, and telephone, and is congested with cardboard boxes, a storage cabinet, wall-mounted artwork, a refrigerator, and various other items. C. The floor is covered with carpet, which makes cleaning difficult.

Observation 4 — Personnel engaged in aseptic processing were observed wearing non-sterile gloves

Personnel engaged in aseptic processing were observed wearing non-sterile gloves. EMPLOYEE(S) SIGNATURE EMPLOYEE{$} NAME AND TIT LE (Print or Type) DATE ISSUED SEE GQ Taichun Qin, Investigator REVERSE OF THIS PAGE 4/3/2025 FORM FOA 483 (9/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Page 2 o f3 -- 2 of 4 -- FORM FDA 483 (9/08) PREVIOUS EDITION OBSO LETE INSPECTIONAL OBSERVATIONS Page 3 of3 ___________________________________________,,_ DEPARTMENT OF HEALTH AND HUMAN SERVICES F OOD AND DRUG ADMINISTRATION DISTRICT OFFICE ADDRESS A ND PHO NE NUMBER OATE(S) OF INSPECTION Denver Federal Center, Building 20 3/25/2025-4/3/2025 Sixth A venue and Kipling Street Denver, CO 80225 FEI NU MB

Observation 5 — Use of a disinfectant in a manner insufficient to achieve adequate levels

Use of a disinfectant in a manner insufficient to achieve adequate levels of disinfection. Specifically, A. Sporicidal agents are not used in the production area. Your firm uses non-sterile wipes and a multi-enzymalic cleanser to clean the production area and utensils. Sporidical agents have never been used, and none are available at your facility. B. Your firm uses non-sterile disinfecting wipes to clean the production area. No sterile wipes intended for cleaning work surfaces were available at your firm. C. The work surface is not disinfected prior to packaging vials into syringes. For example, on 3/25/2025, during the filling of syringes ofTirzepatide/ Cyanocobalamin, ISmg/lmg/mL, Lot# 03065F, BUD: 7/6/2025, from a vial, the operator failed to disinfect the work surfaces with appropriate wipes prior to use.

Observation 6 — Personnel engaged in aseptic processing were observed with exposed hair and skin

Personnel engaged in aseptic processing were observed with exposed hair and skin. Specifically, No gowns, head covers, or masks were used during the filling of syringes intended to be sterile. For example, ,on 3/25/2025, the operator, with exposed hair, did not wear any gown during the filling of syringes with Tirzepatitde/ Cyanocobalamin, 15mg/lmg/mL (5mL), Lot# 03065F, from a vial. SEE REVERSE OF THIS PAGE EMPLOYEE($) NAME AND TITLE (Print or Type) Taichun Qin, Investigator DATE ISSUED 4/3/2025

What a Form 483 means

A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.

Thrive Health and Wellness LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to Thrive Health and Wellness LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

What is an FDA Form 483?: A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
Does this Form 483 mean Thrive Health and Wellness LLC violated the law?: No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
What happens after a Form 483 is issued?: The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
Has Thrive Health and Wellness LLC had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Thrive Health and Wellness LLC so far. Argus ingests new FDA records daily.

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Full FDA history for Thrive Health and Wellness LLC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2025). FDA Inspects Thrive Health and Wellness LLC: Form 483 with 6 Citations (April 3, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-thrive-health-and-wellness-llc-2025-04-03-3033176989

MLA

"FDA Inspects Thrive Health and Wellness LLC: Form 483 with 6 Citations (April 3, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-thrive-health-and-wellness-llc-2025-04-03-3033176989.

Chicago

Argus HQ Research. "FDA Inspects Thrive Health and Wellness LLC: Form 483 with 6 Citations (April 3, 2025)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-thrive-health-and-wellness-llc-2025-04-03-3033176989.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_thrive_health_and_wellness_llc_2025_04_03_3033176989_2025,
  title = {FDA Inspects Thrive Health and Wellness LLC: Form 483 with 6 Citations (April 3, 2025)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-thrive-health-and-wellness-llc-2025-04-03-3033176989},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗