Bio Ser Natural Sa De Cv
⚠️ Moderate Risk
FEI: 3007208895 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3007208895
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle 18 No. 36, Col. Olivar Del Conde 1a. Seccion, Alvaro Obregon, Ciudad De Mexico, Ciudad de Mexico, 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
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.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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 |
|---|---|---|---|
| 2/4/2013 | 64XAU99KERATOLYTIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 2/4/2013 | 64XAU99KERATOLYTIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 12/18/2008 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Bio Ser Natural Sa De Cv's FDA import refusal history?
Bio Ser Natural Sa De Cv (FEI: 3007208895) has 3 FDA import refusal record(s) in our database, spanning from 12/18/2008 to 2/4/2013.
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. Bio Ser Natural Sa De Cv's FEI number is 3007208895.
What types of violations has Bio Ser Natural Sa De Cv received?
Bio Ser Natural Sa De Cv 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 Bio Ser Natural Sa De Cv come from?
All FDA import refusal data for Bio Ser Natural Sa De Cv 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.