Saffron Laboratories
⚠️ Moderate Risk
FEI: 3007280917 • Chonburichonburi • THAILAND
FEI Number
3007280917
Location
Chonburichonburi
Country
THAILANDAddress
32/4 Moo 2 Nong-Gakaphanthong, , Chonburichonburi, , 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
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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/13/2010 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Cincinnati District Office (CIN-DO) | |
| 3/6/2009 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Saffron Laboratories's FDA import refusal history?
Saffron Laboratories (FEI: 3007280917) has 2 FDA import refusal record(s) in our database, spanning from 3/6/2009 to 9/13/2010.
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. Saffron Laboratories's FEI number is 3007280917.
What types of violations has Saffron Laboratories received?
Saffron Laboratories 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 Saffron Laboratories come from?
All FDA import refusal data for Saffron Laboratories 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.