Ssl International
⚠️ Moderate Risk
FEI: 3003862545 • Manchecter • UNITED KINGDOM
FEI Number
3003862545
Location
Manchecter
Country
UNITED KINGDOMAddress
Stake Hill Ind Estate, , Manchecter, , United Kingdom
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/24/2007 | 65CAL09SODIUM PHENYLBUTYRATE (NUTRIENT/TONIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 2/27/2006 | 65CAL09SODIUM PHENYLBUTYRATE (NUTRIENT/TONIC) | New York District Office (NYK-DO) | |
| 1/26/2006 | 65CAL09SODIUM PHENYLBUTYRATE (NUTRIENT/TONIC) | New York District Office (NYK-DO) | |
| 1/26/2006 | 65CAL09SODIUM PHENYLBUTYRATE (NUTRIENT/TONIC) | New York District Office (NYK-DO) | |
| 8/6/2003 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Ssl International's FDA import refusal history?
Ssl International (FEI: 3003862545) has 5 FDA import refusal record(s) in our database, spanning from 8/6/2003 to 8/24/2007.
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. Ssl International's FEI number is 3003862545.
What types of violations has Ssl International received?
Ssl International 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 Ssl International come from?
All FDA import refusal data for Ssl International 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.