Laboratorios Alfa, SRL (Plant)
⚠️ Moderate Risk
FEI: 3003481013 • Pantoja, Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3003481013
Location
Pantoja, Santo Domingo
Country
DOMINICAN REPUBLICAddress
La Isabela Highway, Km 14, Duarte Highway, Pantoja, 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).
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.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/14/2022 | 60LBA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 10/15/2020 | 54YMR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/15/2020 | 60ZKG29PRAZIQUANTEL (ANTIPARASITIC) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 3/23/2017 | 63BCQ01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/30/2016 | 66YDP99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 9/30/2016 | 66YDP99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 5/13/2016 | 61XBA14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 10/27/2011 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/4/2011 | 66YCA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/30/2009 | 68HBA03POULTRY PARASITICIDES (EXTERNAL) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 10/24/2005 | 56BCC05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/8/2005 | 62GCA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 61GBO47SULFADIAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/18/2004 | 54AYY99VITAMIN, N.E.C. | 488HEALTH C | New Orleans District Office (NOL-DO) |
| 11/18/2004 | 66FBL99SUPPRESSANT N.E.C. | 335LACKS N/C | New Orleans District Office (NOL-DO) |
| 5/23/2003 | 60QBJ99ANESTHETIC, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Laboratorios Alfa, SRL (Plant)'s FDA import refusal history?
Laboratorios Alfa, SRL (Plant) (FEI: 3003481013) has 17 FDA import refusal record(s) in our database, spanning from 5/23/2003 to 6/14/2022.
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. Laboratorios Alfa, SRL (Plant)'s FEI number is 3003481013.
What types of violations has Laboratorios Alfa, SRL (Plant) received?
Laboratorios Alfa, SRL (Plant) has been cited for 10 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 Alfa, SRL (Plant) come from?
All FDA import refusal data for Laboratorios Alfa, SRL (Plant) 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.