Procter & Gamble Manufacturing (Thailand) Ltd.
⚠️ High Risk
FEI: 3003150699 • Chachaengsao • THAILAND
FEI Number
3003150699
Location
Chachaengsao
Country
THAILANDAddress
112 Moo 5, , Chachaengsao, , Thailand
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/23/2025 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/23/2025 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/1/2012 | 61HAL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Division of Northeast Imports (DNEI) | |
| 8/1/2012 | 61HAL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Division of Northeast Imports (DNEI) | |
| 8/1/2012 | 61HAL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Division of Northeast Imports (DNEI) | |
| 8/1/2012 | 61HAL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Division of Northeast Imports (DNEI) | |
| 8/1/2012 | 61HAL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Procter & Gamble Manufacturing (Thailand) Ltd.'s FDA import refusal history?
Procter & Gamble Manufacturing (Thailand) Ltd. (FEI: 3003150699) has 7 FDA import refusal record(s) in our database, spanning from 8/1/2012 to 12/23/2025.
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. Procter & Gamble Manufacturing (Thailand) Ltd.'s FEI number is 3003150699.
What types of violations has Procter & Gamble Manufacturing (Thailand) Ltd. received?
Procter & Gamble Manufacturing (Thailand) Ltd. has been cited for 3 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 Procter & Gamble Manufacturing (Thailand) Ltd. come from?
All FDA import refusal data for Procter & Gamble Manufacturing (Thailand) 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.