Biferdil Srl
⚠️ Moderate Risk
FEI: 3003887382 • Capital Federal • ARGENTINA
FEI Number
3003887382
Location
Capital Federal
Country
ARGENTINAAddress
Loyola 722, , Capital Federal, , Argentina
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
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)).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/14/2009 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | 473LABELING | Florida District Office (FLA-DO) |
| 12/14/2009 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 473LABELING | Florida District Office (FLA-DO) |
| 12/14/2009 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 473LABELING | Florida District Office (FLA-DO) |
| 12/14/2009 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | Florida District Office (FLA-DO) | |
| 11/17/2009 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 11/17/2009 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2004 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Biferdil Srl's FDA import refusal history?
Biferdil Srl (FEI: 3003887382) has 7 FDA import refusal record(s) in our database, spanning from 11/5/2004 to 12/14/2009.
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. Biferdil Srl's FEI number is 3003887382.
What types of violations has Biferdil Srl received?
Biferdil 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 Biferdil Srl come from?
All FDA import refusal data for Biferdil 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.