Derclar
⚠️ Moderate Risk
FEI: 3006563617 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3006563617
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Carrera 15 118 45, , Bogota, Cundinamarca, 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
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/10/2007 | 79MFIGLUE, SURGICAL TISSUE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/10/2007 | 56JCP22CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/10/2007 | 54YGP02CARNITINE, VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Derclar's FDA import refusal history?
Derclar (FEI: 3006563617) has 3 FDA import refusal record(s) in our database, spanning from 12/10/2007 to 12/10/2007.
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. Derclar's FEI number is 3006563617.
What types of violations has Derclar received?
Derclar has been cited for 2 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 Derclar come from?
All FDA import refusal data for Derclar 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.