SA TRADING COMPANY
⚠️ Moderate Risk
FEI: 2000047000 • Karachi, Sindh • PAKISTAN
FEI Number
2000047000
Location
Karachi, Sindh
Country
PAKISTANAddress
Suite #6, Alsyed Arcade; Block-5 Gulshan-E-Iqbal, Karachi, Sindh, Pakistan
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).
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.
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 |
|---|---|---|---|
| 2/23/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 2/23/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 2/23/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 7/1/2008 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | New York District Office (NYK-DO) | |
| 7/1/2008 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | New York District Office (NYK-DO) | |
| 7/1/2008 | 33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/1/2008 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is SA TRADING COMPANY's FDA import refusal history?
SA TRADING COMPANY (FEI: 2000047000) has 7 FDA import refusal record(s) in our database, spanning from 7/1/2008 to 2/23/2012.
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. SA TRADING COMPANY's FEI number is 2000047000.
What types of violations has SA TRADING COMPANY received?
SA TRADING COMPANY 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 SA TRADING COMPANY come from?
All FDA import refusal data for SA TRADING COMPANY 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.