Ooo Protek-50
⚠️ High Risk
FEI: 3004706890 • Korolev, Moskovskaya obl • RUSSIA
FEI Number
3004706890
Location
Korolev, Moskovskaya obl
Country
RUSSIAAddress
ul. Lenina 3, , Korolev, Moskovskaya obl, Russia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
© ImportRefusal.com Original Analysis
Violation Summary
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).
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).
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).
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/9/2005 | 80FQMBANDAGE, ELASTIC | New York District Office (NYK-DO) | |
| 9/9/2005 | 80FQMBANDAGE, ELASTIC | New York District Office (NYK-DO) | |
| 9/9/2005 | 80FQMBANDAGE, ELASTIC | New York District Office (NYK-DO) | |
| 9/9/2005 | 80FQMBANDAGE, ELASTIC | New York District Office (NYK-DO) | |
| 9/9/2005 | 62HCA99ANTI-MICROBIAL N.E.C. | New York District Office (NYK-DO) | |
| 9/9/2005 | 62FDL46CAMPHORATED PARACHLOROPHENOL (ANTI-INFECTIVE, TOPICAL) | New York District Office (NYK-DO) | |
| 9/9/2005 | 62MDJ99ANTI-PRURITIC N.E.C. | New York District Office (NYK-DO) | |
| 9/9/2005 | 62FDJ99ANTI-INFECTIVE, TOPICAL N.E.C. | New York District Office (NYK-DO) | |
| 9/9/2005 | 62GDJ99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 9/9/2005 | 61LCJ30HEPARIN CALCIUM (ANTI-COAGULANT) | New York District Office (NYK-DO) | |
| 9/9/2005 | 62MDJ99ANTI-PRURITIC N.E.C. | New York District Office (NYK-DO) | |
| 9/9/2005 | 62MDJ99ANTI-PRURITIC N.E.C. | New York District Office (NYK-DO) | |
| 9/9/2005 | 62MDJ99ANTI-PRURITIC N.E.C. | New York District Office (NYK-DO) | |
| 9/9/2005 | 61HAL99ANTI-BACTERIAL, N.E.C. | New York District Office (NYK-DO) | |
| 9/9/2005 | 62MDL01CAMPHOR (ANTI-PRURITIC) | New York District Office (NYK-DO) | |
| 9/9/2005 | 62FCL20IODINE (ANTI-INFECTIVE, TOPICAL) | New York District Office (NYK-DO) | |
| 9/9/2005 | 62FCL20IODINE (ANTI-INFECTIVE, TOPICAL) | New York District Office (NYK-DO) | |
| 9/9/2005 | 63HAL08CASTOR OIL (CATHARTIC) | New York District Office (NYK-DO) | |
| 9/9/2005 | 62UDA99ANTI-TUSSIVE/COLD N.E.C. | New York District Office (NYK-DO) | |
| 9/9/2005 | 62UDA99ANTI-TUSSIVE/COLD N.E.C. | New York District Office (NYK-DO) | |
| 9/9/2005 | 57AY19ASPARAGINASE ANTITOXIN/ANTIVENIN/ENZYME/VENOM | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Ooo Protek-50's FDA import refusal history?
Ooo Protek-50 (FEI: 3004706890) has 21 FDA import refusal record(s) in our database, spanning from 9/9/2005 to 9/9/2005.
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. Ooo Protek-50's FEI number is 3004706890.
What types of violations has Ooo Protek-50 received?
Ooo 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 Ooo Protek-50 come from?
All FDA import refusal data for Ooo 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.