Protek 50

⚠️ Moderate Risk

FEI: 3005056609 • Moscow, Moscow g • RUSSIA

FEI

FEI Number

3005056609

📍

Location

Moscow, Moscow g

🇷🇺

Country

RUSSIA

🏢

Address

ul. Lenivka 3, , Moscow, Moscow g, Russia

Moderate Risk

FDA Import Risk Assessment

48.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/19/2005

Latest Refusal

6/6/2005

Earliest Refusal

Score Breakdown

Violation Severity

60.0×40%

Refusal Volume

48.2×30%

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

11811×

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).

7510×

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).

4745×

COSMETLBLG

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

3243×

NO ENGLISH

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

Refusal History

Date	Product	Violations	Division
9/19/2005	53LC06MOISTURIZING (SKIN CARE PREPARATIONS)	474COSMETLBLG	New York District Office (NYK-DO)
9/19/2005	53LC06MOISTURIZING (SKIN CARE PREPARATIONS)	474COSMETLBLG	New York District Office (NYK-DO)
9/19/2005	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	474COSMETLBLG	New York District Office (NYK-DO)
9/19/2005	53QD99COSMETIC PACKAGING AND LABELING, N.E.C.	474COSMETLBLG	New York District Office (NYK-DO)
9/19/2005	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	474COSMETLBLG	New York District Office (NYK-DO)
9/19/2005	54FBA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	324NO ENGLISH	New York District Office (NYK-DO)
9/19/2005	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	324NO ENGLISH	New York District Office (NYK-DO)
9/19/2005	54BBA06IODINE (MINERAL)	324NO ENGLISH	New York District Office (NYK-DO)
9/19/2005	66VDK99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/19/2005	62UDA99ANTI-TUSSIVE/COLD N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/19/2005	60SDH99ANTACID, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/19/2005	62GDJ99ANTI-INFLAMMATORY N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/19/2005	66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/19/2005	66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/19/2005	66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/19/2005	66VDA99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/19/2005	62PDJ99ANTI-PYRETIC N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/19/2005	66VDL99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
6/6/2005	80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG)	118NOT LISTED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Protek 50's FDA import refusal history?

Protek 50 (FEI: 3005056609) has 19 FDA import refusal record(s) in our database, spanning from 6/6/2005 to 9/19/2005.

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. Protek 50's FEI number is 3005056609.

What types of violations has Protek 50 received?

Protek 50 has been cited for 4 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 Protek 50 come from?

All FDA import refusal data for Protek 50 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.