Laboratories P.B.E.
⚠️ Moderate Risk
FEI: 3001281578 • Evreux, Eure • FRANCE
FEI Number
3001281578
Location
Evreux, Eure
Country
FRANCEAddress
17 Rue Du Liban, , Evreux, Eure, 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
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 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 |
|---|---|---|---|
| 1/9/2007 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 1/9/2007 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 1/9/2007 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 5/30/2006 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 5/30/2006 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 5/30/2006 | 80LDQDEVICE, GENERAL MEDICAL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratories P.B.E.'s FDA import refusal history?
Laboratories P.B.E. (FEI: 3001281578) has 6 FDA import refusal record(s) in our database, spanning from 5/30/2006 to 1/9/2007.
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 P.B.E.'s FEI number is 3001281578.
What types of violations has Laboratories P.B.E. received?
Laboratories P.B.E. 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 P.B.E. come from?
All FDA import refusal data for Laboratories P.B.E. 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.