Officina Profumo-Farmaceutica
⚠️ Moderate Risk
FEI: 1000206031 • Firenze, FI • ITALY
FEI Number
1000206031
Location
Firenze, FI
Country
ITALYAddress
16 Via Della Scala, , Firenze, FI, 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
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).
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/3/2015 | 63R06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 11/21/2011 | 63SBY99DENTAL PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 11/21/2011 | 33EHT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | New York District Office (NYK-DO) | |
| 4/4/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 4/4/2011 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 9/29/2006 | 54ABC99VITAMIN, N.E.C. | 324NO ENGLISH | New Orleans District Office (NOL-DO) |
| 7/10/2003 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 1/28/2003 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Officina Profumo-Farmaceutica's FDA import refusal history?
Officina Profumo-Farmaceutica (FEI: 1000206031) has 8 FDA import refusal record(s) in our database, spanning from 1/28/2003 to 3/3/2015.
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. Officina Profumo-Farmaceutica's FEI number is 1000206031.
What types of violations has Officina Profumo-Farmaceutica received?
Officina Profumo-Farmaceutica has been cited for 8 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 Officina Profumo-Farmaceutica come from?
All FDA import refusal data for Officina Profumo-Farmaceutica 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.