Milott Laboratories Company Ltd.
⚠️ Moderate Risk
FEI: 1000410270 • Bangplee Samutprakarn • THAILAND
FEI Number
1000410270
Location
Bangplee Samutprakarn
Country
THAILANDAddress
84/55 Moo 11, Soi Tanasit Teparak Road, Bangplee Samutprakarn, , 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).
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/17/2020 | 62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 8/4/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 336INCONSPICU | Division of Northeast Imports (DNEI) |
| 8/22/2017 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/25/2013 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 11/12/2013 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/12/2013 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/12/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/12/2013 | 53LH03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/12/2013 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/12/2013 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/12/2013 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/12/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/12/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/12/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/12/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/12/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/12/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/26/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Milott Laboratories Company Ltd.'s FDA import refusal history?
Milott Laboratories Company Ltd. (FEI: 1000410270) has 18 FDA import refusal record(s) in our database, spanning from 10/26/2012 to 11/17/2020.
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. Milott Laboratories Company Ltd.'s FEI number is 1000410270.
What types of violations has Milott Laboratories Company Ltd. received?
Milott Laboratories Company 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 Milott Laboratories Company Ltd. come from?
All FDA import refusal data for Milott Laboratories Company 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.