FARMAK PRAT
⚠️ Moderate Risk
FEI: 3003768979 • Kyiv, Kyiv • UKRAINE
FEI Number
3003768979
Location
Kyiv, Kyiv
Country
UKRAINEAddress
Bud 63 Vul. Kyrylivska, , Kyiv, Kyiv, Ukraine
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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).
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/20/2017 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Florida District Office (FLA-DO) |
| 6/1/2012 | 61XBK42ANTAZOLINE PHOSPHATE/NAPHAZOLINE HCL (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 5/9/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 1/12/2012 | 60CCL46NAPHAZOLINE HCL (ADRENERGIC) | 472NO ENGLISH | New York District Office (NYK-DO) |
| 10/15/2010 | 65BAN99MUCOLYTIC N.E.C. | New York District Office (NYK-DO) | |
| 9/16/2010 | 60CBY46NAPHAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/19/2010 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/3/2010 | 60CBQ99ADRENERGIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/22/2009 | 61XBL42ANTAZOLINE PHOSPHATE/NAPHAZOLINE HCL (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 12/11/2007 | 66YCA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New York District Office (NYK-DO) | |
| 5/22/2007 | 60CBK99ADRENERGIC N.E.C. | New York District Office (NYK-DO) | |
| 5/22/2007 | 60CBK99ADRENERGIC N.E.C. | New York District Office (NYK-DO) | |
| 5/22/2007 | 61MDL31PHENOBARBITAL (ANTI-CONVULSANT) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/30/2004 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | New York District Office (NYK-DO) |
| 6/9/2003 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is FARMAK PRAT's FDA import refusal history?
FARMAK PRAT (FEI: 3003768979) has 15 FDA import refusal record(s) in our database, spanning from 6/9/2003 to 3/20/2017.
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. FARMAK PRAT's FEI number is 3003768979.
What types of violations has FARMAK PRAT received?
FARMAK PRAT 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 FARMAK PRAT come from?
All FDA import refusal data for FARMAK PRAT 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.