Laboratorios Dr. A. Bjarner C.A.
⚠️ Moderate Risk
FEI: 3009982584 • Guayaquil, Guayas • ECUADOR
FEI Number
3009982584
Location
Guayaquil, Guayas
Country
ECUADORAddress
Unknown, , Guayaquil, Guayas, Ecuador
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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/15/2013 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 3/15/2013 | 66VDO99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/15/2013 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/15/2013 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/15/2013 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Laboratorios Dr. A. Bjarner C.A.'s FDA import refusal history?
Laboratorios Dr. A. Bjarner C.A. (FEI: 3009982584) has 5 FDA import refusal record(s) in our database, spanning from 3/15/2013 to 3/15/2013.
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. Laboratorios Dr. A. Bjarner C.A.'s FEI number is 3009982584.
What types of violations has Laboratorios Dr. A. Bjarner C.A. received?
Laboratorios Dr. A. Bjarner C.A. 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 Laboratorios Dr. A. Bjarner C.A. come from?
All FDA import refusal data for Laboratorios Dr. A. Bjarner C.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.