Oxynergy Paris S

⚠️ Moderate Risk

FEI: 3010088220 • Vilafant, Girona • SPAIN

FEI

FEI Number

3010088220

📍

Location

Vilafant, Girona

🇪🇸

Country

SPAIN

🏢

Address

C Montseny 33, , Vilafant, Girona, Spain

Moderate Risk

FDA Import Risk Assessment

40.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

5/23/2016

Latest Refusal

12/17/2014

Earliest Refusal

Score Breakdown

Violation Severity

55.0×40%

Refusal Volume

38.6×30%

Recency

0.0×20%

Frequency

69.8×10%

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

11810×

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).

32807×

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.

5085×

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.

3412×

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).

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

751×

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
5/23/2016	80LDQDEVICE, GENERAL MEDICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Florida District Office (FLA-DO)
12/14/2015	79GFEBRUSH, DERMABRASION	118NOT LISTED 3280FRNMFGREG	New Orleans District Office (NOL-DO)
10/1/2015	84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
10/1/2015	84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
10/1/2015	84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
10/1/2015	84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
10/1/2015	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
12/17/2014	79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL	118NOT LISTED 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
12/17/2014	79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
12/17/2014	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Oxynergy Paris S's FDA import refusal history?

Oxynergy Paris S (FEI: 3010088220) has 10 FDA import refusal record(s) in our database, spanning from 12/17/2014 to 5/23/2016.

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. Oxynergy Paris S's FEI number is 3010088220.

What types of violations has Oxynergy Paris S received?

Oxynergy Paris S 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 Oxynergy Paris S come from?

All FDA import refusal data for Oxynergy Paris S 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.