Adn Servicios Empresariales
⚠️ Moderate Risk
FEI: 1000610296 • Valencia • VENEZUELA
FEI Number
1000610296
Location
Valencia
Country
VENEZUELAAddress
Cc Guaparo Local Pb 35, , Valencia, , Venezuela
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/23/2003 | 60LCA99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/23/2003 | 56YCA99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/21/2002 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 1/31/2002 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/31/2002 | 60RCB19SIBUTRAMINE HCL MONOHYDRATE (ANOREXIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Adn Servicios Empresariales's FDA import refusal history?
Adn Servicios Empresariales (FEI: 1000610296) has 5 FDA import refusal record(s) in our database, spanning from 1/31/2002 to 9/23/2003.
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. Adn Servicios Empresariales's FEI number is 1000610296.
What types of violations has Adn Servicios Empresariales received?
Adn Servicios Empresariales has been cited for 3 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 Adn Servicios Empresariales come from?
All FDA import refusal data for Adn Servicios Empresariales 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.