Elizabeth Reynoso
⚠️ Moderate Risk
FEI: 3012203357 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3012203357
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
Calle Danai 13 Gazcue, , 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
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.
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/11/2022 | 62FBJ23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | Division of Southeast Imports (DSEI) | |
| 1/11/2022 | 62FBJ23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | Division of Southeast Imports (DSEI) | |
| 1/11/2022 | 62FBJ23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | Division of Southeast Imports (DSEI) | |
| 1/11/2022 | 62FBJ23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | Division of Southeast Imports (DSEI) | |
| 1/11/2022 | 62FBJ23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | Division of Southeast Imports (DSEI) | |
| 11/18/2020 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2016 | 61HBL99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 4/27/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Elizabeth Reynoso's FDA import refusal history?
Elizabeth Reynoso (FEI: 3012203357) has 8 FDA import refusal record(s) in our database, spanning from 4/27/2016 to 1/11/2022.
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. Elizabeth Reynoso's FEI number is 3012203357.
What types of violations has Elizabeth Reynoso received?
Elizabeth Reynoso has been cited for 4 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 Elizabeth Reynoso come from?
All FDA import refusal data for Elizabeth Reynoso 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.