Laboratories Chemineau
⚠️ High Risk
FEI: 3008382474 • Vouvray, Indre-et-Loire • FRANCE
FEI Number
3008382474
Location
Vouvray, Indre-et-Loire
Country
FRANCEAddress
93 Route De Monnaie, , Vouvray, Indre-et-Loire, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/25/2025 | 62FDY99ANTI-INFECTIVE, TOPICAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/20/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2023 | 62HBL99ANTI-MICROBIAL N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/5/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/23/2020 | 66AAY99SPREADING AGENT (FOR INJECTIONS) N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/23/2010 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/17/2009 | 65RAK12POTASSIC SALINE (INJECTION) (REPLENISHER) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Laboratories Chemineau's FDA import refusal history?
Laboratories Chemineau (FEI: 3008382474) has 7 FDA import refusal record(s) in our database, spanning from 11/17/2009 to 6/25/2025.
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 Chemineau's FEI number is 3008382474.
What types of violations has Laboratories Chemineau received?
Laboratories Chemineau has been cited for 3 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 Chemineau come from?
All FDA import refusal data for Laboratories Chemineau 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.