Laboratories Thea
⚠️ High Risk
FEI: 3004991213 • Clermont-Ferrand, Puy-de-Dome • FRANCE
FEI Number
3004991213
Location
Clermont-Ferrand, Puy-de-Dome
Country
FRANCEAddress
12 Rue Louis Bleriot, , Clermont-Ferrand, Puy-de-Dome, France
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/22/2025 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/26/2025 | 65FBY06WATER, PURIFIED (EYEWASH) | Division of Northeast Imports (DNEI) | |
| 4/28/2025 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | Division of Southeast Imports (DSEI) | |
| 10/29/2024 | 65KDY08LATANOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/25/2023 | 64DBL99EMOLLIENT, LUBRICANT, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 9/6/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/18/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/16/2023 | 66VBK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/30/2023 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2022 | 80MDZCLEANERS, MEDICAL DEVICES | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2022 | 78MRESOLUTION, SODIUM HYALURONATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2019 | 65KDY08LATANOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/14/2015 | 86ORZEYELID THERMAL PULSATION SYSTEM | Cincinnati District Office (CIN-DO) | |
| 6/23/2006 | 61XAK99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2006 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/26/2006 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/26/2006 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Laboratories Thea's FDA import refusal history?
Laboratories Thea (FEI: 3004991213) has 17 FDA import refusal record(s) in our database, spanning from 1/26/2006 to 7/22/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Laboratories Thea's FEI number is 3004991213.
What types of violations has Laboratories Thea received?
Laboratories Thea has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Laboratories Thea come from?
All FDA import refusal data for Laboratories Thea is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.