Laboratoria Natury Sp Zoo
⚠️ High Risk
FEI: 3006974235 • Lublin, Lubelskie • POLAND
FEI Number
3006974235
Location
Lublin, Lubelskie
Country
POLANDAddress
Ul. Mariana Rapackiego 19, , Lublin, Lubelskie, Poland
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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 12/3/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 12/3/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 12/3/2010 | 66VAH99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 12/3/2010 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 12/3/2010 | 66VAH99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 12/3/2010 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 11/15/2010 | 25MCE99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | San Francisco District Office (SAN-DO) | |
| 11/15/2010 | 62GBE03ALPHA AMYLASE (ANTI-INFLAMMATORY) | San Francisco District Office (SAN-DO) | |
| 11/15/2010 | 54FCE84MILK THISTLE (HERBAL & BOTANICAL OTHER THAN TEAS) | San Francisco District Office (SAN-DO) | |
| 11/15/2010 | 54CCE09GLYCINE (PROTEIN) | San Francisco District Office (SAN-DO) | |
| 11/15/2010 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | San Francisco District Office (SAN-DO) | |
| 11/15/2010 | 54FCE58SAW PALMETTO (HERBAL & BOTANICALS, NOT TEAS) | San Francisco District Office (SAN-DO) | |
| 7/29/2009 | 54EBH99HERBALS & BOTANICAL TEAS, N.E.C. | 488HEALTH C | Los Angeles District Office (LOS-DO) |
| 7/29/2009 | 54FBK99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/29/2009 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/29/2009 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/29/2009 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/29/2009 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/29/2009 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/29/2009 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/29/2009 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Laboratoria Natury Sp Zoo's FDA import refusal history?
Laboratoria Natury Sp Zoo (FEI: 3006974235) has 22 FDA import refusal record(s) in our database, spanning from 7/29/2009 to 12/3/2010.
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. Laboratoria Natury Sp Zoo's FEI number is 3006974235.
What types of violations has Laboratoria Natury Sp Zoo received?
Laboratoria Natury Sp Zoo has been cited for 3 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 Laboratoria Natury Sp Zoo come from?
All FDA import refusal data for Laboratoria Natury Sp Zoo 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.