BZMP (Borisovskiy Zavod Medicinskikh Preparatov) OAO
⚠️ Moderate Risk
FEI: 3005472282 • Borisov, Minskaya • BELARUS
FEI Number
3005472282
Location
Borisov, Minskaya
Country
BELARUSAddress
Chapaeva 64, , Borisov, Minskaya, Belarus
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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/22/2017 | 60LAA05ASPIRIN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 6/28/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/1/2010 | 64HBL99EXPECTORANT N.E.C. | New York District Office (NYK-DO) | |
| 9/1/2010 | 54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 6/27/2005 | 62FBL20IODINE (ANTI-INFECTIVE, TOPICAL) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is BZMP (Borisovskiy Zavod Medicinskikh Preparatov) OAO's FDA import refusal history?
BZMP (Borisovskiy Zavod Medicinskikh Preparatov) OAO (FEI: 3005472282) has 5 FDA import refusal record(s) in our database, spanning from 6/27/2005 to 5/22/2017.
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. BZMP (Borisovskiy Zavod Medicinskikh Preparatov) OAO's FEI number is 3005472282.
What types of violations has BZMP (Borisovskiy Zavod Medicinskikh Preparatov) OAO received?
BZMP (Borisovskiy Zavod Medicinskikh Preparatov) OAO 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 BZMP (Borisovskiy Zavod Medicinskikh Preparatov) OAO come from?
All FDA import refusal data for BZMP (Borisovskiy Zavod Medicinskikh Preparatov) OAO 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.