Ai Monasteri S.R.L
⚠️ Moderate Risk
FEI: 3004410882 • Roma, RM • ITALY
FEI Number
3004410882
Location
Roma, RM
Country
ITALYAddress
Sede Legale Corso Rinasciment 72, , Roma, RM, 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
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/5/2004 | 66VIK99MISCELLANEOUS PATENT MEDICINES, ETC. | 473LABELING | New Orleans District Office (NOL-DO) |
| 5/5/2004 | 66VIK99MISCELLANEOUS PATENT MEDICINES, ETC. | 473LABELING | New Orleans District Office (NOL-DO) |
| 5/5/2004 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 5/5/2004 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 2/4/2004 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/4/2004 | 33LGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 218LIST INGRE | New Orleans District Office (NOL-DO) |
| 2/4/2004 | 36CGT04HONEY | 218LIST INGRE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ai Monasteri S.R.L's FDA import refusal history?
Ai Monasteri S.R.L (FEI: 3004410882) has 7 FDA import refusal record(s) in our database, spanning from 2/4/2004 to 5/5/2004.
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. Ai Monasteri S.R.L's FEI number is 3004410882.
What types of violations has Ai Monasteri S.R.L received?
Ai Monasteri S.R.L 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 Ai Monasteri S.R.L come from?
All FDA import refusal data for Ai Monasteri S.R.L 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.