Lacofar y CIA Ltda.
⚠️ Moderate Risk
FEI: 3004474606 • Santiago • CHILE
FEI Number
3004474606
Location
Santiago
Country
CHILEAddress
Emiliano Figueroa 851, , Santiago, , Chile
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
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.
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).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/8/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 8/27/2015 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 8/27/2015 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 8/27/2015 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Lacofar y CIA Ltda.'s FDA import refusal history?
Lacofar y CIA Ltda. (FEI: 3004474606) has 4 FDA import refusal record(s) in our database, spanning from 8/27/2015 to 2/8/2016.
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. Lacofar y CIA Ltda.'s FEI number is 3004474606.
What types of violations has Lacofar y CIA Ltda. received?
Lacofar y CIA Ltda. 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 Lacofar y CIA Ltda. come from?
All FDA import refusal data for Lacofar y CIA Ltda. 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.