ALPA, a.s.
⚠️ Moderate Risk
FEI: 3005486756 • Velke Mezirici, Vysocina • CZECH REPUBLIC
FEI Number
3005486756
Location
Velke Mezirici, Vysocina
Country
CZECH REPUBLICAddress
Hornomestska 378/74, , Velke Mezirici, Vysocina, 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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/19/2013 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 7/30/2012 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 7/30/2012 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is ALPA, a.s.'s FDA import refusal history?
ALPA, a.s. (FEI: 3005486756) has 3 FDA import refusal record(s) in our database, spanning from 7/30/2012 to 6/19/2013.
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. ALPA, a.s.'s FEI number is 3005486756.
What types of violations has ALPA, a.s. received?
ALPA, a.s. 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 ALPA, a.s. come from?
All FDA import refusal data for ALPA, a.s. 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.