Laboratory of Modern Health
⚠️ Moderate Risk
FEI: 3007724979 • Berdsk, Novosibirskaya obl • RUSSIA
FEI Number
3007724979
Location
Berdsk, Novosibirskaya obl
Country
RUSSIAAddress
ul. Khimzavodskaya 11/20, , Berdsk, Novosibirskaya obl, Russia
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
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.
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 |
|---|---|---|---|
| 8/31/2017 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 8/25/2015 | 54ACH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 488HEALTH C | Division of Northeast Imports (DNEI) |
| 8/25/2015 | 54ACH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 488HEALTH C | Division of Northeast Imports (DNEI) |
| 12/9/2010 | 54ACH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New York District Office (NYK-DO) | |
| 12/9/2010 | 54ACH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New York District Office (NYK-DO) | |
| 12/9/2010 | 54ACH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New York District Office (NYK-DO) | |
| 12/9/2010 | 54ACH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New York District Office (NYK-DO) | |
| 12/9/2010 | 54ACH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New York District Office (NYK-DO) | |
| 12/9/2010 | 54ACH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New York District Office (NYK-DO) | |
| 12/9/2010 | 54ACH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New York District Office (NYK-DO) | |
| 12/9/2010 | 54ACH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New York District Office (NYK-DO) | |
| 12/9/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/13/2010 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/13/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/13/2010 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/13/2010 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/13/2010 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/13/2010 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/13/2010 | 66VCH99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Laboratory of Modern Health's FDA import refusal history?
Laboratory of Modern Health (FEI: 3007724979) has 19 FDA import refusal record(s) in our database, spanning from 10/13/2010 to 8/31/2017.
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. Laboratory of Modern Health's FEI number is 3007724979.
What types of violations has Laboratory of Modern Health received?
Laboratory of Modern Health 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 Laboratory of Modern Health come from?
All FDA import refusal data for Laboratory of Modern Health 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.