Ooo Globus

⚠️ Moderate Risk

FEI: 3004578660 • St Petersburg • RUSSIA

FEI

FEI Number

3004578660

📍

Location

St Petersburg

🇷🇺

Country

RUSSIA

🏢

Address

5 Razyezhaya Street, , St Petersburg, , Russia

Moderate Risk

FDA Import Risk Assessment

35.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/10/2012

Latest Refusal

10/1/2004

Earliest Refusal

Score Breakdown

Violation Severity

56.1×40%

Refusal Volume

38.6×30%

Recency

0.0×20%

Frequency

13.6×10%

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

1183×

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).

2603×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

753×

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).

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

2181×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

Date	Product	Violations	Division
2/10/2012	03HDT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.	482NUTRIT LBL	New York District Office (NYK-DO)
12/14/2006	31KFH01TEA, BLACK	260FALSE	New York District Office (NYK-DO)
12/14/2006	31KFH01TEA, BLACK	260FALSE	New York District Office (NYK-DO)
12/14/2006	31KFH01TEA, BLACK	260FALSE	New York District Office (NYK-DO)
10/24/2006	31KFH01TEA, BLACK	473LABELING	New York District Office (NYK-DO)
10/24/2006	53LC06MOISTURIZING (SKIN CARE PREPARATIONS)	473LABELING	New York District Office (NYK-DO)
10/24/2006	31KFH01TEA, BLACK	218LIST INGRE	New York District Office (NYK-DO)
10/1/2004	53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
10/1/2004	53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
10/1/2004	53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Ooo Globus's FDA import refusal history?

Ooo Globus (FEI: 3004578660) has 10 FDA import refusal record(s) in our database, spanning from 10/1/2004 to 2/10/2012.

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. Ooo Globus's FEI number is 3004578660.

What types of violations has Ooo Globus received?

Ooo Globus 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 Ooo Globus come from?

All FDA import refusal data for Ooo Globus 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.