Altermed Sro
⚠️ Moderate Risk
FEI: 3005865287 • Olomouc • CZECH REPUBLIC
FEI Number
3005865287
Location
Olomouc
Country
CZECH REPUBLICAddress
Hnevotinska 56, , Olomouc, , Czech Republic
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2007 | 53MC01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/26/2007 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 4/26/2007 | 65LBJ99PROTECTANT N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Altermed Sro's FDA import refusal history?
Altermed Sro (FEI: 3005865287) has 3 FDA import refusal record(s) in our database, spanning from 4/26/2007 to 7/31/2007.
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. Altermed Sro's FEI number is 3005865287.
What types of violations has Altermed Sro received?
Altermed Sro 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 Altermed Sro come from?
All FDA import refusal data for Altermed Sro 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.