Ooo Globus

⚠️ High Risk

FEI: 3008746363 • Sankt-Peterburg, Sankt-Peterburg g • RUSSIA

FEI

FEI Number

3008746363

📍

Location

Sankt-Peterburg, Sankt-Peterburg g

🇷🇺

Country

RUSSIA

🏢

Address

Kozhevennaya liniya 15-4fl, 1-3, KOR., Sankt-Peterburg, Sankt-Peterburg g, Russia

High Risk

FDA Import Risk Assessment

53.2

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

4/26/2011

Latest Refusal

4/26/2011

Earliest Refusal

Score Breakdown

Violation Severity

74.4×40%

Refusal Volume

44.6×30%

Recency

0.0×20%

Frequency

100.0×10%

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

7511×

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).

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.

2232×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

4711×

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.

4741×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

Refusal History

Date	Product	Violations	Division
4/26/2011	53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	471CSTIC LBLG 474COSMETLBLG	New York District Office (NYK-DO)
4/26/2011	54FEA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	260FALSE	New York District Office (NYK-DO)
4/26/2011	54FEA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	260FALSE	New York District Office (NYK-DO)
4/26/2011	54FEA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	260FALSE	New York District Office (NYK-DO)
4/26/2011	53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	223FALSE 75UNAPPROVED	New York District Office (NYK-DO)
4/26/2011	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	223FALSE 75UNAPPROVED	New York District Office (NYK-DO)
4/26/2011	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
4/26/2011	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
4/26/2011	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
4/26/2011	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
4/26/2011	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
4/26/2011	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
4/26/2011	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
4/26/2011	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
4/26/2011	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Ooo Globus's FDA import refusal history?

Ooo Globus (FEI: 3008746363) has 15 FDA import refusal record(s) in our database, spanning from 4/26/2011 to 4/26/2011.

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 3008746363.

What types of violations has Ooo Globus received?

Ooo Globus 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 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.