Pierre Fare Dermo Cosmetique

⚠️ Moderate Risk

FEI: 3006361501 • Lavaur CEDEX • FRANCE

FEI

FEI Number

3006361501

📍

Location

Lavaur CEDEX

🇫🇷

Country

FRANCE

🏢

Address

B.P. 100 Les Cauquillous, , Lavaur CEDEX, , France

Moderate Risk

FDA Import Risk Assessment

38.5

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

9/26/2014

Latest Refusal

8/5/2011

Earliest Refusal

Score Breakdown

Violation Severity

41.0×40%

Refusal Volume

50.4×30%

Recency

0.0×20%

Frequency

70.0×10%

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

Violation Summary

11817×

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).

47215×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

4715×

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.

3351×

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.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5081×

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
9/26/2014	89MOZACID, HYALURONIC, INTRAARTICULAR	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
8/5/2011	53MD01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS)	471CSTIC LBLG	New Orleans District Office (NOL-DO)
8/5/2011	53MD01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS)	471CSTIC LBLG	New Orleans District Office (NOL-DO)
8/5/2011	53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.	471CSTIC LBLG	New Orleans District Office (NOL-DO)
8/5/2011	53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.	471CSTIC LBLG	New Orleans District Office (NOL-DO)
8/5/2011	53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.	471CSTIC LBLG	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 472NO ENGLISH	New Orleans District Office (NOL-DO)
8/5/2011	66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED 335LACKS N/C	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pierre Fare Dermo Cosmetique's FDA import refusal history?

Pierre Fare Dermo Cosmetique (FEI: 3006361501) has 22 FDA import refusal record(s) in our database, spanning from 8/5/2011 to 9/26/2014.

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. Pierre Fare Dermo Cosmetique's FEI number is 3006361501.

What types of violations has Pierre Fare Dermo Cosmetique received?

Pierre Fare Dermo Cosmetique has been cited for 6 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 Pierre Fare Dermo Cosmetique come from?

All FDA import refusal data for Pierre Fare Dermo Cosmetique 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.