Agami Srl
⚠️ Moderate Risk
FEI: 3006375158 • Rome, Rome • ITALY
FEI Number
3006375158
Location
Rome, Rome
Country
ITALYAddress
Via Degli Arvali 29131, , Rome, Rome, 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
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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/30/2007 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 8/30/2007 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 8/30/2007 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 8/30/2007 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 8/30/2007 | 65LAJ11TITANIUM DIOXIDE (PROTECTANT) | New Orleans District Office (NOL-DO) | |
| 8/30/2007 | 65LAJ11TITANIUM DIOXIDE (PROTECTANT) | New Orleans District Office (NOL-DO) | |
| 8/30/2007 | 53CC05EYE MAKEUP REMOVER (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Agami Srl's FDA import refusal history?
Agami Srl (FEI: 3006375158) has 7 FDA import refusal record(s) in our database, spanning from 8/30/2007 to 8/30/2007.
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. Agami Srl's FEI number is 3006375158.
What types of violations has Agami Srl received?
Agami Srl has been cited for 5 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 Agami Srl come from?
All FDA import refusal data for Agami Srl 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.