LABORATORIOS RYSELL, S.A.
⚠️ Moderate Risk
FEI: 3004887033 • Santo Domingo Norte, Distrito Nacional • DOMINICAN REPUBLIC
FEI Number
3004887033
Location
Santo Domingo Norte, Distrito Nacional
Country
DOMINICAN REPUBLICAddress
C/Los Restauradores No. 179, , Santo Domingo Norte, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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 |
|---|---|---|---|
| 1/22/2016 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 473LABELING | San Juan District Office (SJN-DO) |
| 6/11/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 3/8/2007 | 53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 473LABELING | Philadelphia District Office (PHI-DO) |
| 1/19/2007 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is LABORATORIOS RYSELL, S.A.'s FDA import refusal history?
LABORATORIOS RYSELL, S.A. (FEI: 3004887033) has 4 FDA import refusal record(s) in our database, spanning from 1/19/2007 to 1/22/2016.
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 RYSELL, S.A.'s FEI number is 3004887033.
What types of violations has LABORATORIOS RYSELL, S.A. received?
LABORATORIOS RYSELL, S.A. 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 LABORATORIOS RYSELL, S.A. come from?
All FDA import refusal data for LABORATORIOS RYSELL, 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.