Laboratorio Capilo Espanol, SRL
⚠️ Moderate Risk
FEI: 3008224880 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3008224880
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
Calle 19 No.6 Villa Aura, , Santo Domingo, , Dominican Republic
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.
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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/12/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 473LABELING | Division of Southeast Imports (DSEI) |
| 1/12/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 473LABELING | Division of Southeast Imports (DSEI) |
| 1/12/2017 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 473LABELING | Division of Southeast Imports (DSEI) |
| 1/12/2017 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 473LABELING | Division of Southeast Imports (DSEI) |
| 12/1/2014 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 12/4/2013 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 223FALSE | San Juan District Office (SJN-DO) |
| 12/4/2013 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 12/4/2013 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 12/4/2013 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 12/21/2011 | 53ED05RINSES (HAIR PREPARATIONS, NON-COLORING) | New York District Office (NYK-DO) | |
| 12/21/2011 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | New York District Office (NYK-DO) | |
| 3/9/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 6/17/2008 | 61WBL36SALICYLANILIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 6/17/2008 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 2/12/2004 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 473LABELING | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Laboratorio Capilo Espanol, SRL's FDA import refusal history?
Laboratorio Capilo Espanol, SRL (FEI: 3008224880) has 15 FDA import refusal record(s) in our database, spanning from 2/12/2004 to 1/12/2017.
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. Laboratorio Capilo Espanol, SRL's FEI number is 3008224880.
What types of violations has Laboratorio Capilo Espanol, SRL received?
Laboratorio Capilo Espanol, SRL 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 Laboratorio Capilo Espanol, SRL come from?
All FDA import refusal data for Laboratorio Capilo Espanol, 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.