Thai Nakorn Patana Co., Ltd,
⚠️ Moderate Risk
FEI: 3003067499 • Mueang Nonthaburi, Nonthaburi • THAILAND
FEI Number
3003067499
Location
Mueang Nonthaburi, Nonthaburi
Country
THAILANDAddress
14 Thanon Ngamwongwan Soi 8, , Mueang Nonthaburi, Nonthaburi, Thailand
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
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2020 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/11/2020 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/11/2020 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/6/2020 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2020 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/12/2016 | 61XBY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/12/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 12/13/2013 | 60SDC99ANTACID, N.E.C. | 3280FRNMFGREG | San Francisco District Office (SAN-DO) |
| 2/13/2012 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Thai Nakorn Patana Co., Ltd,'s FDA import refusal history?
Thai Nakorn Patana Co., Ltd, (FEI: 3003067499) has 9 FDA import refusal record(s) in our database, spanning from 2/13/2012 to 10/16/2020.
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. Thai Nakorn Patana Co., Ltd,'s FEI number is 3003067499.
What types of violations has Thai Nakorn Patana Co., Ltd, received?
Thai Nakorn Patana Co., Ltd, 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 Thai Nakorn Patana Co., Ltd, come from?
All FDA import refusal data for Thai Nakorn Patana Co., 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.