PHARM-INVEST JV
⚠️ Moderate Risk
FEI: 3012623466 • Chernovcy-Chemihivska • UKRAINE
FEI Number
3012623466
Location
Chernovcy-Chemihivska
Country
UKRAINEAddress
Shevchenko Str 71A, , Chernovcy-Chemihivska, , 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
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)).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/29/2017 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of Northeast Imports (DNEI) | |
| 8/29/2017 | 60SBY04ALUMINUM HYDROXIDE (ANTACID) | Division of Northeast Imports (DNEI) | |
| 8/29/2017 | 60SBY04ALUMINUM HYDROXIDE (ANTACID) | Division of Northeast Imports (DNEI) | |
| 8/29/2017 | 61WBL28SELENIUM SULFIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Northeast Imports (DNEI) | |
| 8/29/2017 | 61MBJ08DIMETHADIONE (ANTI-CONVULSANT) | Division of Northeast Imports (DNEI) | |
| 8/29/2017 | 61WBJ28SELENIUM SULFIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 62FAL17HYDROGEN PEROXIDE (SOL) (ANTI-INFECTIVE, TOPICAL) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 64XBJ06SALICYLIC ACID (KERATOLYTIC) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 63HBJ08CASTOR OIL (CATHARTIC) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 61MBJ08DIMETHADIONE (ANTI-CONVULSANT) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 60LBJ07CAMPHORATED OIL | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 60LBJ07CAMPHORATED OIL | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 61MBJ08DIMETHADIONE (ANTI-CONVULSANT) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 61MBJ08DIMETHADIONE (ANTI-CONVULSANT) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 61MBJ08DIMETHADIONE (ANTI-CONVULSANT) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 60LBJ07CAMPHORATED OIL | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 63HOL08CASTOR OIL (CATHARTIC) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 62MBO08MENTHOL (ANTI-PRURITIC) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 62MBA08MENTHOL (ANTI-PRURITIC) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 60SBJ04ALUMINUM HYDROXIDE (ANTACID) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 62MBL08MENTHOL (ANTI-PRURITIC) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 54ACB01VITAMIN A | 324NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 54FBL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 324NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/29/2017 | 54FBL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 324NO ENGLISH | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is PHARM-INVEST JV's FDA import refusal history?
PHARM-INVEST JV (FEI: 3012623466) has 25 FDA import refusal record(s) in our database, spanning from 8/29/2017 to 8/29/2017.
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. PHARM-INVEST JV's FEI number is 3012623466.
What types of violations has PHARM-INVEST JV received?
PHARM-INVEST JV 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 PHARM-INVEST JV come from?
All FDA import refusal data for PHARM-INVEST JV 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.