Servientrega Internacional
⚠️ Moderate Risk
FEI: 3004192511 • Pereirda • COLOMBIA
FEI Number
3004192511
Location
Pereirda
Country
COLOMBIAAddress
Carrera 33 N 11 B-19 Apt 401, , Pereirda, , Colombia
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2003 | 80MWVNEEDLES, MEDICAMENT DISPENSING TIP & IRRIGATING | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 12/15/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 12/15/2003 | 62GAJ99ANTI-INFLAMMATORY N.E.C. | 472NO ENGLISH | New Orleans District Office (NOL-DO) |
| 12/15/2003 | 79KGXTAPE AND BANDAGE, ADHESIVE | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Servientrega Internacional's FDA import refusal history?
Servientrega Internacional (FEI: 3004192511) has 4 FDA import refusal record(s) in our database, spanning from 12/15/2003 to 12/15/2003.
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. Servientrega Internacional's FEI number is 3004192511.
What types of violations has Servientrega Internacional received?
Servientrega Internacional 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 Servientrega Internacional come from?
All FDA import refusal data for Servientrega Internacional 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.