Laboratoires Osma
⚠️ Moderate Risk
FEI: 1000555804 • Craponne, Metropole de Lyon • FRANCE
FEI Number
1000555804
Location
Craponne, Metropole de Lyon
Country
FRANCEAddress
Lieu Dit Les Tourrais, 110 Voie Romaine, Craponne, Metropole de Lyon, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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).
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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/16/2020 | 64PBY99HEMOSTATIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/30/2013 | 53KI01AFTERSHAVE LOTION (SHAVING PREPARATIONS) | New York District Office (NYK-DO) | |
| 6/11/2012 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratoires Osma's FDA import refusal history?
Laboratoires Osma (FEI: 1000555804) has 3 FDA import refusal record(s) in our database, spanning from 6/11/2012 to 1/16/2020.
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. Laboratoires Osma's FEI number is 1000555804.
What types of violations has Laboratoires Osma received?
Laboratoires Osma has been cited for 10 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 Laboratoires Osma come from?
All FDA import refusal data for Laboratoires Osma 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.