Laboratoire Lpc
⚠️ Moderate Risk
FEI: 3007693973 • Bruz, Ille Et Vilaine • FRANCE
FEI Number
3007693973
Location
Bruz, Ille Et Vilaine
Country
FRANCEAddress
Centre Daffaires Odysee, , Bruz, Ille Et Vilaine, France
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2014 | 68YYY02HORSES ANIMAL DRUGS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 10/16/2014 | 68YYY02HORSES ANIMAL DRUGS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 3/4/2011 | 66VJO99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratoire Lpc's FDA import refusal history?
Laboratoire Lpc (FEI: 3007693973) has 3 FDA import refusal record(s) in our database, spanning from 3/4/2011 to 10/16/2014.
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. Laboratoire Lpc's FEI number is 3007693973.
What types of violations has Laboratoire Lpc received?
Laboratoire Lpc 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 Laboratoire Lpc come from?
All FDA import refusal data for Laboratoire Lpc 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.