Alopecil Corporation, C X A
⚠️ Moderate Risk
FEI: 3002886473 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3002886473
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
Cllae Isabel La Catolica 51, , 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).
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.
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.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/7/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 5/12/2010 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Florida District Office (FLA-DO) | |
| 5/12/2010 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 488HEALTH C | Florida District Office (FLA-DO) |
| 5/12/2010 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 5/12/2010 | 61LBL14CHLORHEXIDINE GLUCONATE | Florida District Office (FLA-DO) | |
| 5/12/2010 | 62FBL17HYDROGEN PEROXIDE (SOL) (ANTI-INFECTIVE, TOPICAL) | Florida District Office (FLA-DO) | |
| 5/12/2010 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/9/2008 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 10/25/2004 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | San Juan District Office (SJN-DO) |
| 10/25/2004 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | San Juan District Office (SJN-DO) |
| 5/12/2004 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 3/15/2002 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 3/15/2002 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 3/15/2002 | 54YCE04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 10/12/2001 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Florida District Office (FLA-DO) | |
| 10/12/2001 | 54YCE04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Alopecil Corporation, C X A's FDA import refusal history?
Alopecil Corporation, C X A (FEI: 3002886473) has 16 FDA import refusal record(s) in our database, spanning from 10/12/2001 to 6/7/2011.
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. Alopecil Corporation, C X A's FEI number is 3002886473.
What types of violations has Alopecil Corporation, C X A received?
Alopecil Corporation, C X 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 Alopecil Corporation, C X A come from?
All FDA import refusal data for Alopecil Corporation, C X 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.