Laboratorios Contifarma, C. Por A.
⚠️ High Risk
FEI: 3008363431 • Santa Domingo • DOMINICAN REPUBLIC
FEI Number
3008363431
Location
Santa Domingo
Country
DOMINICAN REPUBLICAddress
Unknown, , Santa Domingo, , Dominican Republic
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
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).
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).
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).
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/5/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/5/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/5/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/5/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 11/14/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/14/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/14/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/14/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/14/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/14/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/11/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | Florida District Office (FLA-DO) |
| 3/11/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | Florida District Office (FLA-DO) |
| 3/11/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | Florida District Office (FLA-DO) |
| 3/11/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | Florida District Office (FLA-DO) |
| 3/11/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | Florida District Office (FLA-DO) |
| 3/11/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/11/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/11/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/16/2014 | 53L99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | San Juan District Office (SJN-DO) |
| 4/16/2014 | 53L99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | San Juan District Office (SJN-DO) |
| 4/16/2014 | 53L99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | San Juan District Office (SJN-DO) |
| 4/16/2014 | 53L99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | San Juan District Office (SJN-DO) |
| 4/16/2014 | 53L99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 9/14/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | San Juan District Office (SJN-DO) |
| 9/14/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | San Juan District Office (SJN-DO) |
| 9/14/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | San Juan District Office (SJN-DO) |
| 9/14/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | San Juan District Office (SJN-DO) |
| 7/20/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | San Juan District Office (SJN-DO) |
| 3/23/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 117DANGEROUS | San Juan District Office (SJN-DO) |
| 3/23/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 117DANGEROUS | San Juan District Office (SJN-DO) |
| 3/8/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 117DANGEROUS | San Juan District Office (SJN-DO) |
| 3/8/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 117DANGEROUS | San Juan District Office (SJN-DO) |
| 12/5/2011 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 1/24/2011 | 53JG01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | San Juan District Office (SJN-DO) |
| 1/21/2011 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 1/22/2007 | 53UC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/22/2007 | 53JC01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/22/2007 | 53JC01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/19/2004 | 66VBN99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Florida District Office (FLA-DO) |
| 2/19/2004 | 63VDO02HYDROQUINONE (DEPIGMENTOR) | 117DANGEROUS | Florida District Office (FLA-DO) |
| 2/10/2004 | 55QY19PETROLATUM (PHARMACEUTIC NECESSITY - OINTMENT BASE) | 117DANGEROUS | Florida District Office (FLA-DO) |
| 2/10/2004 | 55QY19PETROLATUM (PHARMACEUTIC NECESSITY - OINTMENT BASE) | 117DANGEROUS | Florida District Office (FLA-DO) |
| 2/10/2004 | 55QY19PETROLATUM (PHARMACEUTIC NECESSITY - OINTMENT BASE) | 117DANGEROUS | Florida District Office (FLA-DO) |
| 12/10/2003 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 473LABELING | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53RD05HAIR PREPARATIONS (NON-COLORING), COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 473LABELING | San Juan District Office (SJN-DO) |
| 10/24/2001 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 10/24/2001 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 10/24/2001 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 10/24/2001 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 10/24/2001 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 10/24/2001 | 64ABY20TRICLOSAN (DISINFECTANT) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Laboratorios Contifarma, C. Por A.'s FDA import refusal history?
Laboratorios Contifarma, C. Por A. (FEI: 3008363431) has 52 FDA import refusal record(s) in our database, spanning from 10/24/2001 to 6/5/2017.
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. Laboratorios Contifarma, C. Por A.'s FEI number is 3008363431.
What types of violations has Laboratorios Contifarma, C. Por A. received?
Laboratorios Contifarma, C. Por A. 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 Laboratorios Contifarma, C. Por A. come from?
All FDA import refusal data for Laboratorios Contifarma, C. Por A. 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.