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Centro Botanico Internacional

⚠️ Moderate Risk

FEI: 3003459655 • Mexico, D.F. • MEXICO

FEI

FEI Number

3003459655

📍

Location

Mexico, D.F.

🇲🇽

Country

MEXICO
🏢

Address

Manzanares Esq. Pradera, Col. Merced, Centro, Mexico, D.F., Mexico

Moderate Risk

FDA Import Risk Assessment

36.9
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
3
Unique Violations
11/27/2001
Latest Refusal
11/27/2001
Earliest Refusal

Score Breakdown

Violation Severity
74.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

162×

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.

752×

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).

1181×

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).

Refusal History

DateProductViolationsDivision
11/27/2001
66VIE99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
16DIRECTIONS
75UNAPPROVED
Southwest Import District Office (SWI-DO)
11/27/2001
66VIL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Centro Botanico Internacional's FDA import refusal history?

Centro Botanico Internacional (FEI: 3003459655) has 2 FDA import refusal record(s) in our database, spanning from 11/27/2001 to 11/27/2001.

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. Centro Botanico Internacional's FEI number is 3003459655.

What types of violations has Centro Botanico Internacional received?

Centro Botanico Internacional 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 Centro Botanico Internacional come from?

All FDA import refusal data for Centro Botanico Internacional 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.