Gelcaps Exportadora de Mexico, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3004345715 • Naucalpan De Juarez, Mexico • MEXICO
FEI Number
3004345715
Location
Naucalpan De Juarez, Mexico
Country
MEXICOAddress
Calle 7 Fracc. Alce Blanco, , Naucalpan De Juarez, 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
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).
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).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/7/2023 | 62UCA01BENZONATATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2022 | 60SDY99ANTACID, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/11/2021 | 61XCY18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/8/2017 | 56JCY31CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 54YYH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 8/24/2016 | 56JDJ20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Gelcaps Exportadora de Mexico, S.A. de C.V.'s FDA import refusal history?
Gelcaps Exportadora de Mexico, S.A. de C.V. (FEI: 3004345715) has 6 FDA import refusal record(s) in our database, spanning from 8/24/2016 to 2/7/2023.
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. Gelcaps Exportadora de Mexico, S.A. de C.V.'s FEI number is 3004345715.
What types of violations has Gelcaps Exportadora de Mexico, S.A. de C.V. received?
Gelcaps Exportadora de Mexico, 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 Gelcaps Exportadora de Mexico, S.A. de C.V. come from?
All FDA import refusal data for Gelcaps Exportadora de Mexico, 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.