Tokyo Plast International Ltd.
⚠️ Moderate Risk
FEI: 3002665859 • Mumbai India • INDIA
FEI Number
3002665859
Location
Mumbai India
Country
INDIAAddress
Tokyo House, 9/49 Marol Co-Op Industrial, , Andheri (E), Mumbai India, , India
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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 |
|---|---|---|---|
| 1/21/2004 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/24/2003 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/24/2003 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 10/8/2003 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/8/2003 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/15/2003 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/3/2002 | 62MBJ08MENTHOL (ANTI-PRURITIC) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Tokyo Plast International Ltd.'s FDA import refusal history?
Tokyo Plast International Ltd. (FEI: 3002665859) has 7 FDA import refusal record(s) in our database, spanning from 12/3/2002 to 1/21/2004.
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. Tokyo Plast International Ltd.'s FEI number is 3002665859.
What types of violations has Tokyo Plast International Ltd. received?
Tokyo Plast International Ltd. 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 Tokyo Plast International Ltd. come from?
All FDA import refusal data for Tokyo Plast International Ltd. 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.