Centro Botanico Plantimex, S.A. De C.V.
⚠️ High Risk
FEI: 3003450799 • D.F • MEXICO
FEI Number
3003450799
Location
D.F
Country
MEXICOAddress
Ave. Palmitas # 52 Col. Palmitas, , Iztapalapa, Mexico, D.F, , Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/24/2002 | 60LBJ63SALICYLAMIDE (ANALGESIC) | Southwest Import District Office (SWI-DO) | |
| 6/11/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 1/7/2002 | 60LBJ63SALICYLAMIDE (ANALGESIC) | Southwest Import District Office (SWI-DO) | |
| 1/7/2002 | 60LIJ63SALICYLAMIDE (ANALGESIC) | Southwest Import District Office (SWI-DO) | |
| 1/7/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/7/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/7/2002 | 60LIJ99ANALGESIC, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/28/2001 | 60LBJ63SALICYLAMIDE (ANALGESIC) | Southwest Import District Office (SWI-DO) | |
| 12/19/2001 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/19/2001 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/19/2001 | 60LIJ63SALICYLAMIDE (ANALGESIC) | Southwest Import District Office (SWI-DO) | |
| 12/19/2001 | 60LIJ63SALICYLAMIDE (ANALGESIC) | Southwest Import District Office (SWI-DO) | |
| 12/12/2001 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/12/2001 | 60LIJ99ANALGESIC, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 60LBJ63SALICYLAMIDE (ANALGESIC) | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 66VIJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 60LBJ63SALICYLAMIDE (ANALGESIC) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Centro Botanico Plantimex, S.A. De C.V.'s FDA import refusal history?
Centro Botanico Plantimex, S.A. De C.V. (FEI: 3003450799) has 18 FDA import refusal record(s) in our database, spanning from 11/27/2001 to 6/24/2002.
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 Plantimex, S.A. De C.V.'s FEI number is 3003450799.
What types of violations has Centro Botanico Plantimex, S.A. De C.V. received?
Centro Botanico Plantimex, S.A. De C.V. 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 Centro Botanico Plantimex, S.A. De C.V. come from?
All FDA import refusal data for Centro Botanico Plantimex, S.A. De C.V. 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.