BEWELL D O O

⚠️ Moderate Risk

FEI: 3012504353 • Postojna, Notranjsko-Kraska • SLOVENIA

FEI

FEI Number

3012504353

📍

Location

Postojna, Notranjsko-Kraska

🇸🇮

Country

SLOVENIA

🏢

Address

Kolodvorska cesta 5B, , Postojna, Notranjsko-Kraska, Slovenia

Moderate Risk

FDA Import Risk Assessment

43.0

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

4/14/2021

Latest Refusal

5/10/2017

Earliest Refusal

Score Breakdown

Violation Severity

55.4×40%

Refusal Volume

49.0×30%

Recency

5.2×20%

Frequency

50.9×10%

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).

328017×

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.

50812×

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.

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).

4751×

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.

Refusal History

Date	Product	Violations	Division
4/14/2021	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/5/2021	84QLKSTIMULATOR, NEUROMUSCULAR, LOWER BACK MUSCLES, TOTALLY IMPLANTED FOR PAIN RELIEF	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
1/29/2021	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/24/2020	84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF	508NO 510(K)	Division of Southeast Imports (DSEI)
10/27/2020	80NRWSTIMULATOR, INTRAMUSCULAR, AUTOMATIC	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
9/15/2020	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
9/3/2020	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED 237NO PMA 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
8/26/2020	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED	Division of Southeast Imports (DSEI)
8/6/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
8/6/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
7/27/2020	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
6/8/2020	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
6/5/2020	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
6/1/2020	89NYZSTIMULATOR, MUSCLE, POWERED, WITH LIMITED OUTPUT, FOR MUSCLE CONDITIONING	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
12/3/2019	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/18/2019	89ISBSTIMULATOR, MUSCLE, DIAGNOSTIC	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
5/17/2019	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
1/30/2019	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
5/10/2017	53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)	475COSMETLBLG	Division of Southeast Imports (DSEI)
5/10/2017	73KOISTIMULATOR, NERVE, PERIPHERAL, ELECTRIC	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BEWELL D O O's FDA import refusal history?

BEWELL D O O (FEI: 3012504353) has 20 FDA import refusal record(s) in our database, spanning from 5/10/2017 to 4/14/2021.

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. BEWELL D O O's FEI number is 3012504353.

What types of violations has BEWELL D O O received?

BEWELL D O O has been cited for 5 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 BEWELL D O O come from?

All FDA import refusal data for BEWELL D O O 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.