Haba Laboratories Inc.
⚠️ Moderate Risk
FEI: 3009286836 • Chiyoda-ku, Tokyo-to • JAPAN
FEI Number
3009286836
Location
Chiyoda-ku, Tokyo-to
Country
JAPANAddress
12411 Kanda Sudacho Chiyoda Ku, , Chiyoda-ku, Tokyo-to, Japan
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2019 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 473LABELING | Division of Southeast Imports (DSEI) |
| 5/25/2016 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/25/2016 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/25/2016 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Haba Laboratories Inc.'s FDA import refusal history?
Haba Laboratories Inc. (FEI: 3009286836) has 4 FDA import refusal record(s) in our database, spanning from 5/25/2016 to 9/3/2019.
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. Haba Laboratories Inc.'s FEI number is 3009286836.
What types of violations has Haba Laboratories Inc. received?
Haba Laboratories Inc. has been cited for 2 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 Haba Laboratories Inc. come from?
All FDA import refusal data for Haba Laboratories Inc. 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.