Yaniez Barron Jose Armando
⚠️ Moderate Risk
FEI: 3005741875 • Puebla • MEXICO
FEI Number
3005741875
Location
Puebla
Country
MEXICOAddress
16 De Septiembre No 4910 Planta Las, , Puebla, , Mexico
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
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 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 |
|---|---|---|---|
| 11/27/2007 | 61EDL08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/27/2007 | 64HDL02GUAIFENESIN (EXPECTORANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/27/2007 | 56ACK99PENICILLIN NATURAL, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 5/29/2007 | 65JDK31PROGESTERONE (PROGESTIN) | Cincinnati District Office (CIN-DO) | |
| 5/24/2007 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/2/2007 | 80KZHINTRODUCER, SYRINGE NEEDLE | Cincinnati District Office (CIN-DO) | |
| 3/16/2007 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Yaniez Barron Jose Armando's FDA import refusal history?
Yaniez Barron Jose Armando (FEI: 3005741875) has 7 FDA import refusal record(s) in our database, spanning from 3/16/2007 to 11/27/2007.
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. Yaniez Barron Jose Armando's FEI number is 3005741875.
What types of violations has Yaniez Barron Jose Armando received?
Yaniez Barron Jose Armando has been cited for 5 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 Yaniez Barron Jose Armando come from?
All FDA import refusal data for Yaniez Barron Jose Armando 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.