Rafael A. Castillo
⚠️ Moderate Risk
FEI: 3008357570 • Santo Domingo De Guzman, Distrito Nacional • DOMINICAN REPUBLIC
FEI Number
3008357570
Location
Santo Domingo De Guzman, Distrito Nacional
Country
DOMINICAN REPUBLICAddress
Oll Tercera 33, , Santo Domingo De Guzman, Distrito Nacional, 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
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.
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).
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/13/2022 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 3/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/26/2012 | 61HBL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED05RINSES (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/20/2012 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/4/2011 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 197COSM COLOR | New York District Office (NYK-DO) |
| 5/4/2011 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 197COSM COLOR | New York District Office (NYK-DO) |
| 2/24/2011 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Rafael A. Castillo's FDA import refusal history?
Rafael A. Castillo (FEI: 3008357570) has 31 FDA import refusal record(s) in our database, spanning from 2/24/2011 to 10/13/2022.
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. Rafael A. Castillo's FEI number is 3008357570.
What types of violations has Rafael A. Castillo received?
Rafael A. Castillo has been cited for 6 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 Rafael A. Castillo come from?
All FDA import refusal data for Rafael A. Castillo 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.