Pharmacie De Strasbourg
⚠️ Moderate Risk
FEI: 3002726327 • Paris, Paris • FRANCE
FEI Number
3002726327
Location
Paris, Paris
Country
FRANCEAddress
12 boulevard de Strasbourg, , Paris, Paris, 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
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).
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.
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.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/2/2014 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 3/1/2013 | 53AF99OTHER BABY PRODUCTS, N.E.C. | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 12/1/2004 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Pharmacie De Strasbourg's FDA import refusal history?
Pharmacie De Strasbourg (FEI: 3002726327) has 3 FDA import refusal record(s) in our database, spanning from 12/1/2004 to 5/2/2014.
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. Pharmacie De Strasbourg's FEI number is 3002726327.
What types of violations has Pharmacie De Strasbourg received?
Pharmacie De Strasbourg has been cited for 7 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 Pharmacie De Strasbourg come from?
All FDA import refusal data for Pharmacie De Strasbourg 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.