Pendura Inter Laboratories (Asia) Co Ltd
⚠️ Moderate Risk
FEI: 3009045310 • Bangkok • THAILAND
FEI Number
3009045310
Location
Bangkok
Country
THAILANDAddress
6 Prasertmanukrit 29 Yak 10,, , Bangkok, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/20/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/20/2011 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/20/2011 | 53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/20/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/20/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Pendura Inter Laboratories (Asia) Co Ltd's FDA import refusal history?
Pendura Inter Laboratories (Asia) Co Ltd (FEI: 3009045310) has 5 FDA import refusal record(s) in our database, spanning from 10/20/2011 to 10/20/2011.
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. Pendura Inter Laboratories (Asia) Co Ltd's FEI number is 3009045310.
What types of violations has Pendura Inter Laboratories (Asia) Co Ltd received?
Pendura Inter Laboratories (Asia) Co Ltd 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 Pendura Inter Laboratories (Asia) Co Ltd come from?
All FDA import refusal data for Pendura Inter Laboratories (Asia) 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.