Laboratorios Roldan S.A.
⚠️ Moderate Risk
FEI: 3003138396 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3003138396
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
Carretera Sanchez Av Independencia, KM 5, , 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
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).
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
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/26/2024 | 64ABU05CRESOL (DISINFECTANT) | Division of Northeast Imports (DNEI) | |
| 6/26/2024 | 64ABU05CRESOL (DISINFECTANT) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/14/2021 | 64ACY20TRICLOSAN (DISINFECTANT) | 2280DIRSEXMPT | Division of Southeast Imports (DSEI) |
| 10/14/2021 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Division of Southeast Imports (DSEI) |
| 9/20/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 9/20/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 3/23/2012 | 60LBL07CAMPHORATED OIL | 472NO ENGLISH | San Juan District Office (SJN-DO) |
| 3/8/2012 | 60LBJ07CAMPHORATED OIL | 472NO ENGLISH | San Juan District Office (SJN-DO) |
| 3/22/2010 | 65TBY04SULFUR (SCABICIDE) | San Juan District Office (SJN-DO) | |
| 8/22/2003 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Laboratorios Roldan S.A.'s FDA import refusal history?
Laboratorios Roldan S.A. (FEI: 3003138396) has 10 FDA import refusal record(s) in our database, spanning from 8/22/2003 to 6/26/2024.
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 Roldan S.A.'s FEI number is 3003138396.
What types of violations has Laboratorios Roldan S.A. received?
Laboratorios Roldan S.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 Roldan S.A. come from?
All FDA import refusal data for Laboratorios Roldan S.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.