Sinerga S.p.A.
⚠️ Moderate Risk
FEI: 3005488671 • Gorla Maggiore, Varese • ITALY
FEI Number
3005488671
Location
Gorla Maggiore, Varese
Country
ITALYAddress
Via Della Pacciarna 67, , Gorla Maggiore, Varese, Italy
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
REDUCED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug that a substance has been mixed or packed with so as to reduce its strength.
FORBIDDEN
The article is subject to refusal of admission pursuant to Section 801(a)(2) in that it appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/9/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 4/9/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 4/9/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 4/9/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 4/9/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 4/9/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 4/9/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 4/9/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 5/6/2013 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/2/2013 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/2/2013 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 66YDL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Sinerga S.p.A.'s FDA import refusal history?
Sinerga S.p.A. (FEI: 3005488671) has 12 FDA import refusal record(s) in our database, spanning from 1/28/2010 to 4/9/2021.
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. Sinerga S.p.A.'s FEI number is 3005488671.
What types of violations has Sinerga S.p.A. received?
Sinerga S.p.A. has been cited for 9 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 Sinerga S.p.A. come from?
All FDA import refusal data for Sinerga S.p.A. 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.